U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 

National Institutes of Health 

Centers for Disease Control and Prevention 

U.S. ENVIRONMENTAL PROTECTION AGENCY 
20072008. It outlines the key research questions and introduces the approaches Study leaders 

take for involving 100,000 families in the Study over a 21-year period. 

Between now and its actual start, National Children’s Study planners will complete the process 

under way to develop the specific details of many aspects of the Study, including design features

research questions, how participants will be selected, and what participation will include. Althou

the design of the Study is still in development, it is important to share news of this research 

program—even before all of its components are fully determined—due to the Study’s potential 

and early levels of interest that have been expressed. 
gy py 

today that keeps so many children from enjoying healthy lives? A large number of health studies have 

brought us closer to identifying root causes of diseases, but none to date has undertaken such a compre

look at the early lifespan—from prenatal months through young adulthood—with such high hopes for 

providing answers as the National Children’s Study. 

The National Children’s Study reaffirms the federal government’s commitment to the health and well b

children by drawing together the nation’s top experts on child health and the environment in an unprece

collaboration. Multiple federal agencies, national non-profit groups, community health care providers, 

more than 100,000 families stand poised to help child health move forward in the 21st century. The g

the Study complement government efforts to challenge individuals, communities, and professionals to 

action to ensure that good health and long life are enjoyed by all. The Study also supports national goa

enhance education, for instance, by exploring the role of children’s environments on their readiness to 

Undertaking a study of this magnitude will be neither effortless, nor automatic. To be successful over m

years, and for tens of thousands of families to participate, the National Children’s Study will require a 

significant mobilization of people, funding, and leadership at all levels. It requires careful attention to p

confidentiality, timing for reporting Study findings, and ethical considerations that arise in research inv

children. This effort cannot go forward without the enthusiasm of scientists throughout the country, no

it meet its objectives without the support of local community institutions and organizations. 

Participating in the National Children’s Study has been compared to planting a tree—the gift the partic

provides today may not necessarily benefit the individual, but its value will grow over time, improving 

children’s lives for years to come. Embarking on a long journey is filled with anticipation and ripe with 

and opportunity for what will be discovered along the way. With the support of the country, the Nation

Children’s Study will have the opportunity to give our children the healthy and happy lives they deserv

Pa
Page 2
 
Economic Investment in Health Research: Better Health, Better Returns.......................................

A Tradition of Landmark Studies ..................................................................................................

Studying an Increasingly Diverse Nation of Children....................................................................

Priority Theme Areas of the National Children’s Study..................................................................

■ Pregnancy-Related Outcomes...............................................................................................

■ Injury...................................................................................................................................

■ Asthma.................................................................................................................................

■ Obesity, Diabetes, and Physical Development.......................................................................

■ Child Development and Mental Health ................................................................................

■ Genetics ...............................................................................................................................

■ Physical Environment...........................................................................................................

■ Chemical Environment.........................................................................................................

■ Psychosocial Environment....................................................................................................

■ Biologic Environment...........................................................................................................

Growing and Learning: A Child’s Development ............................................................................

MOVING FORWARD: MEETING THE CHALLENGES OF THE NATIONAL CHILDREN’S STUDY

Laying the Groundwork: Pilot Studies and Discussion Groups......................................................

Planned Approaches to Study Challenges......................................................................................

2 

■ Children as Research Participants.........................................................................................

■ Participant Confidentiality....................................................................................................

■ Protecting Participants (Informed Consent)..........................................................................

■ Participant Recruitment........................................................................................................

■ Participant Retention............................................................................................................

EXPRESSING THE VISION FOR THE NATIONAL CHILDREN’S STUDY.....................................

The Health and Economic Benefits of the National Children’s Study.............................................

REFERENCES ..............................................................................................................................

3 

4 

Pa
Page 4
 
CHILDRENS STUDY 

Pa
Executive Summary: 

The National Children’s 

Study at a Glance 

Page 6
 
involve 100,000 children, from before birth to age 

21, to better understand the link between the 

environments in which children are raised and their 

physical and mental health and development. For 

the Study, the “environment” is defined broadly to 

include physical surroundings; biological and 

chemical factors; geography; and social, educational, 

behavioral, family, and cultural influences. By linking 

multiple environmental factors to multiple health and 

developmental outcome measures, the Study has the 

ability to pinpoint the root causes of many of today’s 

major childhood diseases and disorders, and to 

determine not only which aspects of the environment 

are harmful, but also which are harmless or helpful 

to children’s health and development. 

WHAT ISSUES WILL THE STUDY 

FOCUS ON? 

The National Children’s Study is framed by a set 

of key scientific research questions that include 

some of the most pressing health and development 

concerns for children today. Designed as a 

longitudinal cohort study, it will examine participants’ 

growth and development over time. The Study will 

produce information of unprecedented value for 

scientists, health professionals, and families about 

multiple concerns in child health and development, 

including pregnancy-related outcomes, obesity, 

diabetes, asthma, injury, and social behavior. By 

incorporating and applying new scientific and 

The National Children’s Study will provide 

essential information about many serious he

conditions and threats to optimum physical 

mental development. The Study will build a v

data storehouse touching many areas of conc

and need—and will even be prepared to answ

questions that scientists and the public have ye

Unlike studies that seek answers to a single qu

the Study will address multiple questions toge

provide as much information as possible. Exam

such questions include: In what specific ways 

prenatal exposures to pesticides linked to an in

risk for learning and developmental disabiliti

How do viral infections in early childhood in

subsequent development of asthma? How do 

chemical exposures and social factors interact 

child development? How do various environm

factors interact with certain genes in children 

young adults? And as these interactions occur

are disease or health altered in the present or la

WHY NOW? 

A confluence of events points to the need for 

study on children’s health in the beginning 

21st century. The Collaborative Perinatal Pro

the last major long-term study of American chil

took place in the 1960s, and its findings are ou

by technology standards and lifestyle differen

Meanwhile, the rates of obesity, asthma, autis

some other common childhood diseases and di

Pa
There is also a societal and economic need for the 

National Children’s Study data. The annual costs to 

the American economy associated with the priority 

health and disease outcomes addressed by the 

National Children’s Study currently total in the 

hundreds of billions of dollars (see page 27). 

With indicators showing that healthy children have 

better school attendance, learn better, and are more 

likely to grow up to be productive workers and 

family members, now is the time to pursue a 

long-term study of factors influencing the health 

and development of the nation’s children. 

Today’s scientists and other researchers are better 

equipped than their predecessors to undertake the 

challenges posed by the Study. Technology now 

exists to collect and analyze the vast amounts of 

data the Study will deliver. New tools make possible 

measurements of exposure to many environmental 

influences. There are now better means to keep 

participant records safe and confidential. And, with 

the completion of the human genome sequence in 

2003, there is an extraordinary opportunity to 

analyze the interactions between genetic and 

environmental factors that affect health. 

WHY FOCUS THE RESEARCH ON 

CHILDREN? 

Children are not simply “little adults.” Their 

immature systems often make them more vulnerable 

than adults to environmental exposures. And young 

findings on the effects of lead on child developme

or findings of the impact of maternal alcohol use 

the fetus highlight the need for concern about 

environmental exposures and children’s developin

systems. Past lessons like these form a key rationa

for exploring the effects of other potentially seriou

environmental influences on children. 

WHO WILL BE INVOLVED? 

The National Children’s Study will recruit mor

than 100,000 women from across the United 

States who are likely to have a child in the near 

future. These women will constitute a cross sectio

of ethnic, geographic, and socioeconomic groups 

and will be representative of the national populati

The Study plans to start recruitment in 2007–200

and expand nationwide in 2008–2009. By includ

families from varied backgrounds and family 

structures, the Study can better investigate issues 

of vital interest to all communities. 

WHO IS LEADING THE STUDY? 

The National Children’s Study will be a 

collaborative effort involving a host of public a

private partners committed to improving 

children’s health. The U.S. Department of Health 

and Human Services (HHS)—through the Nation

Institutes of Health (NIH) and Centers for Disease 

Control and Prevention (CDC)—and the U.S. 

Environmental Protection Agency (EPA) are leadin

Page 8
 
participating in advisory and consultative groups and, 

in some instances, are helping to design and guide 

the Study. As the Study evolves, the consortium will 

maintain partnerships to ensure that the Study is 

addressing the pressing public health problems of 

the nation. The consortium, together with its 

partners, will sustain the Study over the next two 

decades and ensure that all organizations, agencies, 

and groups are focused on common goals. 

WHAT WILL WE GET FROM THE 

NATIONAL CHILDREN’S STUDY— 

AND WHEN? 

The National Children’s Study will identify earlylife exposures that affect individuals before birth, 

during childhood, and throughout the rest of 

their lives. It will provide researchers, health care 

providers, educators, and others who work with 

children with a resource of data from which to 

develop prevention strategies, health and safety 

guidelines, educational approaches, and, possibly, 

new treatments and cures for health conditions. In 

addition, the Study will help to prove or disprove 

many theories of child health and development that 

are speculative today. For the first time, a Study will 

allow researchers to apply knowledge of the human 

genome on a large scale and to understand the 

conditions that arise from many factors, including 

gene/environment interactions. It will provide 

answers to questions about children’s health and 

development for many years. Researchers wil

need to wait for the completion of the Study 

analyze the results. Beginning with birth outc

findings will become available within two to 

years after the Study is launched. Throughou

Study’s duration, intermittent results will allo

continued insights. 

WHY SHOULD I GET INVOLVED W

THE NATIONAL CHILDREN’S ST

By supporting the National Children’s Stud

whether through expertise, communication

community resources, participation in the 

or other ways, you will be helping to impro

health and well being of children for years 

come. The success of the Study rests solely on 

participation and support of health care prov

scientists and other researchers, educators, 

community leaders and liaisons, child health 

environmental advocacy and support groups, 

makers, and, of course, those who volunteer 

participate in the Study and their families. 

Pa
Why the National 

Children’s Study? 

Page 10
 
gg, p

physically active lives, helped to keep them at healthy weights. 

But 50 years ago, pesticides were used routinely in our yards a

kitchens. Pregnant women were not commonly advised to avoi

cigarettes or alcohol. Type 2 diabetes was considered an adult 

disease. The diagnosis of Attention Deficit/Hyperactivity Disord

(ADHD) did not exist. Physicians rarely treated asthma. Babies 

were placed on their stomachs to sleep. 

In the years since, research has brought about significant improvem

in children’s health. Today, caregivers are urged to place infants 

their backs to reduce the risk of Sudden Infant Death Syndrom

(SIDS). Lead has been removed from house paint and gasoline 

after being linked to reduced IQ in children.1 Cribs, high chair

and playground equipment are now safer, and most parents wou

even think of transporting their children without car safety restra

Pag
collectively are estimated to affect 17 percent—nearly 

one in every five—school-age children.4,5 And even 

though the infant mortality rate in our increasingly 

diverse society has reached an all-time low, and the 

proportion of mothers receiving early prenatal care 

is at a record high, disparities in care and outcomes 

remain among racial and ethnic groups, presenting 

a host of challenges for many families.6 

A CHANGING AMERICA 

As many health and safety practices from past 

generations have been validated or dismissed based 

on new evidence, we have come to understand that 

the environments our children live in are profoundly 

important. From the air they breathe to the food 

they eat, from where they live to how they live, the 

United States. Yet, with the prevalence of these 

conditions remaining stubbornly persistent, or on 

the rise, few studies can confirm more definitive 

links that lead to prevention strategies. In additio

with the threats of terrorism, violence, and other 

stress-inducers becoming facts of daily life for ma

families, understanding and protecting our childr

health and safety is a national priority. 

Everyone is worried about the health and 

education of our children. Parents and 

grandparents—we all want to do right by 

our children.We need a scientific base for 

what we are doing because our children’s 

future is at stake. 

Lynn R. Goldman, M.D., M.P.H., professor, 

Environmental Health Sciences, Johns Hopkins 

Bloomberg School of Public Health 

WHY STUDY CHILDREN? 

Compared with adults, children: 

■ Have a greater vulnerability to 

environmental exposures; 

■ Have immature mechanisms for 

detoxification and protection; 

■ Have several critical windows of 

vulnerability, especially before birth; 

■ Have differences in metabolism that cause 

different reactions to the same exposures; 

and 

■ Spend more time on the ground and put 

objects in their mouths. 

Page 12
 
Children are not simply “little adults.” Because of 

differences in both physiology and behavior, what 

we understand about how adults interact with their 

environments does not necessarily apply to children. 

For instance, children tend to be more vulnerable to 

environmental threats because their developing systems 

cannot effectively resist and break down toxicants.7 

In response to growing concerns over children’s 

health and development, a partnership of 

government, community, advocacy, and private 

organizations is planning this long-term, observational 

study of how health and development during the 

first 21 years of life are affected by physical, chemical, 

biological, and psychosocial environments. 

The environment is defined broadly in the 

National Children’s Study to include natural 

and man-made environmental factors, 

biologic and chemical factors, physical 

surroundings, social factors, psychological 

influences and outcomes, cultural and family 

influences, and geographic locations. 

The National Children’s Study will observe 

approximately 100,000 children in the United 

States from before birth to their 21st birthdays, 

and possibly beyond. The Study seeks to dete

not only what is harmful, but what is harmles

helpful to children’s health and development. 

Study will measure exposures to, and relation

with, an array of environmental factors. Initial 

research findings will be published soon after 

birth of the children. Findings will continue to 

published throughout the duration of the Stud

We need to get really basic facts about 

all these diseases. It all starts in childho

William Castelli, M.D., former director, 

the Framingham Heart Study 

The Study will be uniquely positioned to exam

and assess a multitude of elements and aspects 

participating children’s lives, from the construc

world of neighborhoods and schools, to chemi

exposures linked to the atmosphere, water sup

or food, to the interactions of birth history, fam

patterns, and the frequency and severity of spe

diseases. This ability to examine multiple expo

and link them in cause-effect relationships wit

multiple outcomes is the defining characteristi

National Children’s Study. The Study’s trajector

encompass pregnancy-related influences, inclu

latent or unrecognized prenatal infections, the 

Pag

Community characteristics: neighborhood 

safety, access to health care 

■ Activity and diet: sports, food additives, inhome versus takeout meals 
human genome, genetic assays, and new computing 

technologies will further enhance the Study’s power. 

By implementing various tools of connection and 

collaboration among biologic, physical, engineering, 

computer, and clinical sciences, the Study’s outcomes 

promise to be of fundamental importance not only 

for medical diagnostics and health care, but also for 

educational strategies, city planning, public policy, 

and environmental regulation. 

PRIORITY FOR OUR TIMES: 

A STUDY OF HEALTH OUTCOMES 

AND EXPOSURES 

The rationale for the National Children’s Study stems 

from a consensus within the research community 

that new and reliable data on factors responsible for 

child health are needed. Previous studies established 

vital scientific foundations, including some information 

enough to draw definitive conclusions to many 

outstanding child health and development questio

In formulating the National Children’s Study’s key 

areas of emphasis, hundreds of scientists and 

representatives from community and professional 

organizations helped to identify and articulate 

important children’s environmental health question

These core hypotheses encompass many importan

child health outcomes and exposures that are bes

studied for long-term follow-up and this particula

research design. They establish both a scientific 

framework as well as a “public identity” for the 

National Children’s Study. 

The National Children’s Study Interagency 

Coordinating Committee used the findings from 2

National Children’s Study working groups, as wel

reviews of children’s environmental health literatu

Page 14
 

With its emphasis on multiple health 

outcomes and environmental exposures 

among a cohort of 100,000 children, the 

National Children’s Study combines scientific 

power and cost-effectiveness. By evaluating 

data across exposures, the Study will help 

create a complete picture of what actually 

causes diseases and influences health. 
p

diagnosing and treating diseases in the future

and comments from a broad-based Study Assembly 

to develop initial hypotheses. Although the 

hypotheses ensure that specific research areas will be 

included in the Study, they do not, by themselves, 

convey its true breadth. The full scope of the Study 

encompasses these hypotheses in tandem with the 

priority outcomes and exposures outlined below. 

Together, they represent an approach to addressing 

the nation’s most urgent public health concerns. 

PRIORITY HEALTH OUTCOME 

THEMES 

Pregnancy-Related Outcomes. Can good nutrition 

help overcome potential risks from other 

environmental exposures that can affect the fetus? 

How does infection at various times over the course 

of pregnancy impact the fetus? 

Injury. What are the links between childhood 

injuries and risk-taking behaviors? How do city and 

neighborhood planning and construction encourage 

or discourage injuries? How do genes and the 

environment interact to promote or prevent violent 

behavior in teenagers? How do innate characteristics, 

parenting, and peer relationships influence risk 

taking, persistent aggression, and risk of injury? 

Asthma. What really causes asthma and how 

be prevented? Can very early exposure to som

allergens actually help children remain asthm

How do the multiple factors contributing to a

interact to result in the disease? 

Obesity, Diabetes, and Physical Developmen

lack of exercise and poor diet the only reason

children are overweight? How do genes and t

environment interact to encourage obesity? H

social, behavioral, and family factors that affe

development of dietary preferences and physi

activity patterns in early childhood determine 

risk of childhood obesity? 

Child Development and Mental Health. How 

exposures to environmental toxicants, stress, 

natal nutrition, and other factors, such as gen

linked to a child’s risk of autism, ADHD, and 

developmental disorders? 

We are pleased that the goals of the 

proposed national study will encompas

our basic mission of understanding the 

complex components of adverse birth 

outcomes, including birth defects, 

prematurity, and low birth weight, as a 

critical route to improving child health. 

Nancy Green, M.D., medical director, 

March of Dimes 

Pag
Social Environment 

Physical Environment 

Medicine and Pharmaceuticals 

Development and Behavi

Growth 

Fertility and Pregnancy 

Health Care 

A broad range of possible exposures must be examined to pinpoint causes of the potential outcomes. The National Children’s Study is 

uniquely positioned to uncover these complex interactions to address today’s health concerns and also those of tomorrow. 

GENETICS 

In what ways do environmental factors intersect 

with genes? How do mutations and variations in 

genes affect the development of diseases? 

PRIORITY EXPOSURES 

The five priority environmental exposure groups 

discussed below may have a profound influence 

(either beneficial or deleterious) on child health 

and development. 

Physical Environment. Do aspects of the physical 

environment, such as housing quality and 

neighborhood and community conditions, affect 

child health and development? What about the 

influence of physical factors, such as radiation 

(e.g., electromagnetic, ultrasound, microwave, 

X-ray), as well as light and noise? 

Chemical Environment. What happens to the 

human organism after long periods of low-dose 

exposure to chemicals, pesticides, and herbicides

What are the health effects associated with compl

low-level exposures? 

Psychosocial Environment. How do school 

environments, emotional stress, family conflict, an

personal relationships affect the physical and men

health of children? 

Biologic Environment. How do bacteria, viruses, 

toxins, and diet influence immunity, inflammation

and diseases, such as diabetes? Do infections imp

developmental progress, asthma, obesity, and hea

disease? How do molecular and genetic mechanism

interact with viruses and bacteria in the expressio

of disease? 

If the Study finds significant effects of 

chemicals on health, we can enhance our 

risk management of chemicals and other 

environmental influences and make changes. 

Lee Salamone, director, Public Health Team, 

American Chemistry Council 

Page 16
 
environment 

National in scope: 

involving children 

from diverse ethnicities 

and socioeconomic 

backgrounds 

A national resource 

for future studies 

environments 

Large enough to 

identify causes of 

important, but less 

common diseases 

and conditions 

The first nationwide 

children’s study 

to benefit 

from human 

genome mapping 

A public-private 

partnership of 

government, private 

industry, and community 

organizations 

asthma, and pregnan

related outcomes 

Using state-of-the-a

technology to captu

data and track 

developments 

Scheduled to 

announce first findin

in 2009–2010 

Pag
today and in the future. 

WHAT PARTICIPANTS WILL BE 

ASKED TO DO 

The National Children’s Study will recruit women 

who are pregnant, or who may soon become 

pregnant, to assess fetal and maternal health. It 

will also observe participating children and their 

families as they grow and live. 

Unlike a clinical trial, in which participants take 

medication or engage in a prevention or treatment 

activity, an observational study like the National 

Children’s Study collects information about 

participants’ lifestyles in the home, at school, and 

at play. Families will visit a participating Study site on 

a few occasions during the baby’s first year of life and 

less frequently in subsequent years. During the visits, 

health professionals will collect samples such as urine, 

blood, hair, DNA from parents and grandparents, and 

other information regarding the child’s environment 

and health status. Families can expect to receive 

information about the research findings from Study 

coordinators by phone, mail, and the Internet, and 

through home visits. In home visits, a nurse or health 

research assistant will confer with the parents or 

caregivers to collect samples of indoor and outdoor 

air, water, or other environmental components. 

two decades—no small challenge in today’s mobi

society. The National Children’s Study will promo

its research results through scientific journal articl

Web site postings, and media outreach activities. 

A UNIQUE PARTNERSHIP 

The National Children’s Study is a collaborative ef

led by the U.S. Department of Health and Human 

Services (HHS)—through the National Institutes o

Health (NIH) and the Centers for Disease Control 

and Prevention (CDC)—and the U.S. Environmen

Protection Agency (EPA). Operating through the NI

National Institute of Child Health and Human 

Development (NICHD), the Study benefits from t

input of more than 40 other federal agencies and 

departments. Study planners hope to build 

partnerships among local communities, health ca

providers, and federal and non-federal scientists, 

well as parent, advocacy, and private industry grou

that will inform the Study throughout its duration a

will ensure the greatest benefit to the nation’s childr

The National Children’s Study has the potential to 

fill knowledge gaps, make a positive impact on th

lives of children and adults, and generate the 

knowledge to find cures and maintain healthy liv

Everyone involved—families, researchers, policy 

makers, and the children themselves—will offer a 

gift to future generations through their support o

and participation in the Study. 

Page 18
 
The benefits of the Natio

Children’s Study will exte

far beyond the U.S. borde

What is learned about 

American children and th

environments can help 

people around the world. 

Pag
The Genesis of the 

National Children’s 

Study: Children’s 

Health Act of 2000 

Page 20
 
physical environments and social settings, and a far less diverse 

population of children. Studies conducted since, although offe

important insights, have been too small or too specific to analy

the wide range of environmental factors and relationships that 

National Children’s Study will address. 

With many childhood diseases and unhealthy conditions on th

rise over the past two decades, support has grown for a broad 

partnership of agencies to join forces in conducting an extensiv

study of children’s health. Such a study would develop an 

important data resource and would yield powerful clinical and 

research tools at a substantial cost savings over separate studies 

conducted by individual agencies. 

Pag
passage of the Children’s Health Act of 2000 (Public 

Law 106–310). Among other provisions, this act 

authorized the development of the National 

Children’s Study. President George W. Bush has 

twice reauthorized the Task Force, and Congress has 

demonstrated continued interest in the National 

Children’s Study by requesting briefings on Study 

plans and expected outcomes. 

The President’s Task Force on 

Environmental Health and Safety 

Risks to Children was established in 

1997 by executive order.The Task 

Force was instrumental in highlighting 

the need for the National Children’s 

Study, and its members from 16 

departments and White House 

offices continue to be a strong 

source of support. 

Congress has demonstrated continued 

support for the National Children’s Study sin

passing the Children’s Health Act of 2000. 

An Interagency Coordinating Committee, 

comprising scientists from each lead agency with 

oversight by the NICHD director, was formed to 

guide the Study’s planning and implementation. A 

federal advisory committee and 20 working group

composed of federal and non-federal scientists an

other representatives have made substantial progr

informing various aspects of the Study. 

Initial funds for fiscal years 2000 through 2004 w

contributed by the lead agencies. Congress has al

remained supportive, as reflected by language in 

appropriations committee reports. Numerous 

interagency partnerships have been established to 

plan the components of this ambitious long-term 

study and to conduct pilot studies. 

Page 22
 
Pag
Economic Investment in 

Health Research: Better 

Health, Better Returns 

Page 24
 
New findings in medical research make the news every day, be 

gene therapy, bionic hearts, the regeneration of nerve cells, or t

latest breakthrough in real-time medical imaging. As discoverie

become practical tools, they help confirm that funding for med

research is a sound investment. But at this start of a new centu

biomedical research is facing some of its most significant 

challenges. Although the goals of health research are clear— 

realizing health benefits for all people—the debate over cost 

continues in all quarters, from health care professionals and 

researchers to policy makers, educators, and concerned citizen

Pag
and medical procedures.8 The report concluded that 

for every research dollar invested, two to three 

dollars are returned to the economy. 

Specific economic advantages of the National 

Children’s Study—which is projected to cost an 

average of $100 million per year, or $2.7 billion 

over 25 years—can be viewed from the perspective 

of direct cost reduction. Five of the Study’s major 

health outcome theme areas encompass diseases 

and conditions that currently create a societal 

burden of more than $750 billion per year.9-15 This 

figure is all the more troubling because it represents 

both treatment and intervention for conditions 

that research has shown can be mitigated and 

possibly prevented. 

Previous studies, similar in some ways to the National 

Children’s Study, have demonstrated significant 

economic benefits. For instance, groundbreaking 

1970s research on the effects of lead on children’s 

neurodevelopment prompted the phasing out of lead 

Page 26
 

supplements as prevention strategies.18 These 

measures have produced tangible economic bene

as well; for example, the annual net economic bene

of fortification has been estimated to be $94 millio

In addition to health care costs saved, an important 

less quantifiable economic aspect is human potentia

realized due to optimal health. Healthier children h

greater school attendance, learn better, and are mor

likely to grow up to be productive workers and fam

members. By generating findings that can help child

grow into healthy and dynamic adult members of 

society, the National Children’s Study will yield a 

valuable “return on investment.” What we have now

a result of the Framingham Heart Study, is a powerf

link between scientific data and health care practi

In mounting a complex, multifaceted, collaborativ

medical study involving thousands of participants

Framingham researchers not only broke new 

ground, but also learned that research provides 

benefits that can only be partially understood wh

a study begins. 

A sustained research effort would greatly improve 

the understanding of diseases and could stimulate 

innovative strategies to limit the impact of 

conditions, ultimately reducing the nation’s health 

care costs. 
Diabetes 

$132 Billionc 

Asthma 

$14 Billiond 

Neurobehavioral Disorders 

$9.2 Billione 

Low Birth Weigh

$6 Billionf 

Total 

$758.7 Billio

Note: The above figures are adopted from a range of sources that may have used varying methods and assumptions in calc

a.	 National Safety Council. (1999). Report on injuries in America 

[Electronic version]. Retrieved November 17, 2003, from 

http://www.nsc.org/lrs/statinfo/99report.htm 

b.	 Centers for Disease Control and Prevention, DHHS. (n.d.). 

Improving nutrition and increasing physical activity [Electronic 

version]. Retrieved October 12, 2004, from 

http://www.cdc.gov/nccdphp/bb_nutrition/ 

c.	 American Diabetes Association. (2003). Economic costs of 

diabetes in the U.S. in 2002. Diabetes Care, 26(3), 917-932. 

d.	 American Lung Association. (2003, March). Trends in asthma 

morbidity and mortality [Electronic version]. Retrieved October 21, 

2004, from http://www.lungusa.org/atf/cf/%7B7A8D42C2-FCCA4604-8ADE-7F5D5E762256%7D/ASTHMA1.PDF 

e.	 Landrigan, P. J., Schechter, C. B., Lipton, J. M., Fahs, M. 

& Schwartz, J. (2002). Environmental pollutants and dis

American children: Estimates of morbidity, mortality, and 

lead poisoning, asthma, cancer, and developmental disab

Environmental Health Perspectives, 110(7), 721–728. 

f.	 Lewitt, E. M., Baker, L. S., Corman, H., & Shiono, P. H. 

The direct cost of low birthweight. The Future of Children

35–56. 

g.	 Silverstein, S. C., Garrison, H. H., & Heinig, S. J. (1995)

basic economic facts about research in the medical and r

sciences. The Federation of American Societies for Experime

Biology Journal 9(10), 833–840. 

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A Tradition of 

Landmark Studies 

Page 28
 
y yp

diseases and conditions. 

The Collaborative Perinatal Project, launched in 1959 by th

NIH’s National Institute of Neurological Diseases and Blindnes

(now the National Institute of Neurological Disorders and Stro

followed more than 40,000 pregnant women and their children 

until 1974. The study contributed some of the most important 

information ever collected on rubella during pregnancy,20 as we

as some of the first understandings of the effects of fetal exposu

to alcohol and lead. It also demonstrated that febrile seizures 

in infancy do not demand treatment and improved our 

understanding of cerebral palsy. The Collaborative Perinatal 

Project was one of the first studies to yield insights on SIDS.21 

Data from the study created an important resource on many 

children’s health issues, including the impact of pregnancy 

outcomes and the effects of social and economic variables on 

the health of individual children. 

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smoking, overweight and obesity, elevated 

cholesterol and blood pressure levels, and lack of 

exercise as risk factors for heart disease.23-27 The 

challenges accepted by the study’s originators 

have long since translated into significant health 

improvements for people around the world,28 and 

literally billions of dollars have been saved through 

reduced health care costs.29 

The findings from the Framingham Heart 

Study revealed that high blood pressure is a 

risk factor for stroke as well as heart disease 

(1961, 1970); that women’s risk for heart 

disease increases after menopause (1976); 

and that psychological and social factors have 

profound effects on heart health (1978).30 

The Bogalusa Heart Study, the longest and most 

detailed children’s heart health study, was launched 

in 1972 and is scheduled to end in 2005. Focusing 

on participants from birth to age 31, it has 

confirmed that high blood pressure and heart 

disease can begin in childhood (with documented 

effects as early as age five), and that the nature of 

heart disease risk factors among children differs 

from that of adults. The study has also validated 

connections between environmental factors and 

too. Big studies are costly but yield 

enormous benefits. 

Phil Landrigan, M.D., M.Sc., professor and chairman

Department of Community and Preventive 

Medicine, Mount Sinai School of Medicine 

The Nurses’ Health Study, launched in 1976, 

looked at the risk factors for major chronic diseas

in women. The Nurses’ Health Study II was 

launched in 1989 as a long-term evaluation of the 

effects of oral contraceptives, diet, and lifestyle 

factors on women’s health. Each study has involve

more than 100,000 nurses and has verified that 

heart disease risk is reduced among women who 

take a daily multivitamin; that women who eat 

certain types of fish on a regular basis have a lowe

incidence of heart disease; that healthy lifestyles 

significantly lower the incidence of heart disease; 

and that cigarette smoking is associated with 

increased heart-disease risk, particularly among 

women with diabetes.33 

The Women’s Health Initiative, launched in the 

mid-1990s, is an observational study of 150,000 

postmenopausal women between the ages of 50 

and 79 over a 15-year span. The study focuses on 

hormone therapy (HT), diet, calcium, and Vitami

D supplementation, and the relationships of these 

Page 30
 
and complexity are necessary to reveal the intricate 

patterns of human biology, as well as the subtle 

relationships between causes and effects that can be 

expressed as diseases. These multifaceted research 

efforts, which involve thousands of participants, 

continue to provide keys to medical knowledge and 

idea came to be popular in the 1980s.T

study was also very influential in how w

manage jaundice in babies, even today. 

Mark Klebanoff, M.D., director, Division of 

Epidemiology, Statistics, and Prevention Resear

NICHD 

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Studying an 

Increasingly Diverse 

Nation of Children 

Page 32
 
of life. It also seeks to eliminate health disparities, specifically th

based on gender, race, and ethnicity; income and education; an

disability. The nation recognizes that, although great strides ha

been made in addressing health disparities, much work remain

The Children’s Health Act of 2000 calls upon the National 

Children’s Study to involve diverse populations, and to assess 

health disparities among the nation’s children. The Study will h

uncover differences among groups of people in terms of health

health care access, and disease rates, allowing disparities to be 

identified and addressed. The Study participants will be as 

representative as possible of the overall U.S. population at the 

beginning of the 21st century—a population much more diver

than even a decade ago, and becoming more so each year. 

Pag
children in the United States37). Meanwhile, the 

percentage of Asian American/Pacific Islander 

children doubled (from 2 percent to 4 percent) 

in the last 20 years.38 

But despite vigorous population growth, many 

American children today face significant health 

challenges related to an array of factors. Some 

children confront poverty and poor access to health 

care, as well as violence, language barriers, and 

exposures to air and water pollution. In growing 

numbers, they also face diseases—such as diabetes 

and heart disease—exacerbated by high-fat diets and 

lack of physical activity. 

A few select facts underscore the pressing need for 

greater knowledge about the health and well being of 

our nation’s children. Mexican American boys are most 

affected by obesity. Puerto Rican children have the 

highest prevalence of asthma—11 percent—of any 

also suffering from depression and substance abu

disproportionately, with a suicide rate 1.5 times the 

national rate.46,47 In addition, American Indian/Alask

Native infants are unduly burdened by Fetal Alco

Syndrome, with an incidence at least twice the 

national average.48 

A major challenge [in the Study] will be 

having a balanced sample representing the 

U.S. as it is now.You are going to see 

emerging populations over the next 20 

years.The Latino population and other 

ethnic groups are growing extremely fast, 

and we are going to have to account for the 

changing demographics of the United States

Tom Curtin, M.D., chief medical officer, National 

Association of Community Health Centers 

By mounting a broad-scale investigation of our 

increasingly diverse nation of children, the Study 

can learn from the socioeconomic and health 

successes of the last two decades. For example, ov

Closing the gaps in health among the nation’s 

children is among the federal government’s 

highest health priorities. 

Page 34 
Asian 2,772,235 

Native Hawaiian and Other Pacific Islander 148,927 

Reporting Hispanic or Latino Origin* 

Hispanic or Latino 13,588,755 

*	 U.S. Census Bureau population estimates as of July 1, 2003. The U.S. Census considers race and Hispanic origin two separate c

and therefore Hispanics may be of any race or races. Source: U.S. Census Bureau (2004). National population estimates character

[Electronic version]. Retrieved September 22, 2004, from http://www.census.gov/popest/national/asrh/NC-EST2003-asrh.html 

the last 20 years there have been significant gains in 

the number of Hispanic middle-class households,49 

and today more than half of African American 

married couples have incomes higher than 

$50,000.50 Improved birth weights are evident 

among Hispanic infants, and their mortality rates 

are close to those of non-Hispanic white infants.51 

Infants born to Asian American/Pacific Islander 

mothers have the lowest infant mortality rate of any 

U.S. ethnic or racial group overall.52 In addition, low 

birth weight babies are less common (6.0 percent) 

among American Indian/Alaska Natives than all 

children combined (the national rate is 7.3 percent).53 

By adding to and analyzing these kinds of data more 

comprehensively than ever before, the National 

Children’s Study can develop the insights needed to 

answer pressing questions about the full range of 

racial, ethnic, and socioeconomic contexts that 

compose the national fabric. The Study will b

unique and balanced power to the examinatio

diversity. To realize this opportunity fully, the 

will seek the participation of a varied group o

families—particularly the women and childre

as pivotal contributors. To ensure that health 

disparities are adequately addressed, the Nati

Children’s Study will recruit extra participant

some diverse populations. Study coordinators 

identify women through multiple venues, fro

doctors’ offices and community clinics, to soc

service and community groups. Study inform

will be disseminated through many outlets, 

including churches, libraries, retail outlets, an

community centers. And, because participant 

retention can be more difficult for families de

with poverty, transportation problems, and geo

isolation, the National Children’s Study will d

ways to make participation easier for them. 

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Priority Theme Areas 

of the National 

Children’s Study 

Page 36
 
scope of the National Children’s Study, or the ability to assess 

interactions among many exposures and related health outcom

in a large population of children. 

By using a trio of key features—time (20-plus years), number 

of participants (100,000), and the array of scientific tools now 

available to investigators—the National Children’s Study will b

able to deliver new perspectives on many of the nation’s most 

pervasive child health questions. With new analytical techniqu

brought to bear, such as DNA microarrays (“gene chips”) and h

speed processing of biological samples, the Study will seek to 

address the exposures and conditions that represent the most 

significant risks and burdens to U.S. children. 

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settings or environments. 

Today, the number of childhood conditions 

with suspected environmental connections 

comprises a daunting list.There is compelling 

evidence that obesity, cancer, asthma, autism, 

birth defects, and cerebral palsy all carry 

significant environmental linkages. 

In meeting the challenge to create a large-scale 

database, the National Children’s Study will respond 

to the evolution of scientific thinking across the next 

20 years, including improvements in data collection, 

as well as innovations in various research tools and 

techniques. Most important, though, the Study will 

center its efforts around a number of broadly 

defined health outcome and exposure themes that 

are considered to have the greatest overall impact on 

child health and development. Some of these issues 

include obesity, diabetes, and physical development; 

injury; asthma; pregnancy-related outcomes; 

outcomes related to child development and mental 

health; exposures to psychosocial, physical, 

chemical, and biologic environments; and the 

influence of genes and genetic variation on 

environmental exposures. By maintaining broadly 

defined areas of interest, the Study preserves the 

flexibility to respond to new and unforeseen 

questions as they arise. 

conditions. Using the organizing principle of 

interrelated “priority theme areas,” the National 

Children’s Study will optimize the research effort 

across a variety of health concerns, generating 

a powerful scientific resource that can shed 

unexpected light on new questions for years to co

The following discussions highlight several priori

theme areas, outlining the basic nature of the pub

health challenges in each case. In offering key 

questions that might guide investigators, a numbe

of promising approaches and strategies emerge. T

avenues of investigation are too numerous to cite 

each and every possibility, but a number of specif

Study questions have been developed to ensure th

key measures are obtained, and that the sample o

participants and study design are adequate for the 

questions to be addressed. 

Among other things, the National 

Children’s Study will provide us with 

critical information on the relationship 

between housing and health and [will] 

improve our understanding of the 

association between the built environment 

and autism, respiratory ailments, obesity, 

childhood injury, and other areas that 

concern us all. 

Peter J.Ashley, Dr.P.H., environmental scientist, U.S. 

Department of Housing and Urban Development, 

Office of Healthy Homes and Lead Hazard Contro

Page 38
 
Addressing Pregnancy-Related Outcomes Is pre-term birth caused by inflammation a

The National Children’s Study will investigate a infection? Evidence of intrauterine infection i

range of important research questions related to present in up to 40 percent of all spontaneou

pregnancy and events that occur within one year term births and up to 75 percent of those tha

after the end of pregnancy, including birth defects, before 32 weeks’ gestation.58, 59 Recent reports 

low birth weight, pre-term births, miscarriage, also linked pre-term births to maternal tooth 

stillbirth, and neonatal problems. Some research gum disease, and to inflammation in other pa

questions include: the body.60 The Study can collect cervical and 

Does impaired glucose metabolism during vaginal cultures and histological material as e

pregnancy as possible to assess for local and pregnancy increase the risk of birth defects? 

systemic inflammatory markers. At birth, plac

Evidence suggests an increased risk of birth defects 

material and umbilical cord blood can be exa

among children born to women who are diabetic 

for indications of infection and inflammation

before or during pregnancy.57 The Study will assess 

Linkage to obstetric records may provide othe

the presence of impaired maternal glucose 

metabolism, a diabetes precursor, as early as evidence of infection to help answer this ques

possible in the course of pregnancy. Children born 

to women with this condition will be 

comprehensively assessed for evidence of birth 

defects. Results from this effort can help revise 

standards of care for prenatal screening, as well as 

inform guidelines for the management of diabetes 

during pregnancy. 

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Addressing Injury 

Past studies on the causes of childhood injuries have 

provided data needed to pass informed laws and 

develop proactive interventions, such as free smoke 

detector programs and child safety caps on medicine 

bottles.66, 67 By identifying groups at increased risk 

due to genetic and other factors, the National 

Children’s Study aims to build upon this knowledge 

base to inform interventions for subgroups of 

children at greatest risk of injury. Potential research 

questions concerning injury include: 

How do innate individual characteristics, such as 

resting heart rate or biologic level of reactivity 

and other genetic traits, along with parenting and 

peer environments, influence risk taking, 

aggressive behavior, and unintentional injury? 

Improved understanding of biologically based 

measures of reactivity in infancy holds great promise 

for insights into why some individuals exhibit highrisk behaviors, while others do not. Animal studies 

on the interaction of genes and environment in 

shaping behavior offer a strong foundation for 

observing similar elements in children—and 

for pointing the way to science-based injuryprevention programs. 

Does repeated head trauma adversely affect 

neurodevelopment? Although the classic setting 

repeated head trauma is athletic competition—wi

sports-related injuries accounting for some 20 perc

of the 1.5 million traumatic brain injuries sustain

annually—normal childhood activities also provid

ample opportunity for repetitive, mild head traum

The Study can consider traumatic brain injuries o

varying severity based on interviews, school and 

medical records, and sports participation data and 

can assess the resulting neurodevelopmental chang

Page 40
 
asthma-promoting genes are believed to be affected by environmental exposures, particularly in ea

life.There is some evidence that dust mites, cockroach allergens, and tobacco smoke can cause ast

but more research is needed to examine a variety of early-life airborne exposures that may be rela

the onset of asthma.74 

Addressing Asthma 

Several research questions for the National 

Children’s Study address the possible influence of 

fetal or early-life exposures on subsequent risk of 

asthma, including: 

Does indoor and/or outdoor air pollution cause 

asthma? There is clear evidence that air pollution 

exacerbates asthma, but whether unhealthy air 

initiates asthma is less certain. The National 

Children’s Study can estimate exposure to specific 

indoor and outdoor air pollutants by sampling air 

quality in and around participants’ homes and 

schools, through activity diaries, using personal air 

samplers for some participants, and linking to 

existing data about outdoor air. 

Is early-life infection associated with asthma risk? 

Some studies have suggested that early-life infections 

protect against asthma, while others conclude the 

opposite.75 To confirm or deny the relationship of 

infections and asthma, early exposures to infectious 

diseases can be investigated through family 

interviews, illness histories, blood tests, day care 

attendance, and the number of siblings. The Study 

can collect maternal and umbilical cord-blood 

samples to assess exposures to infectious agents, 

conduct interviews with parents and caregiver

possibly review medical records. In addition, b

samples can be collected to evaluate immune 

response and inflammatory factors. The Study 

best contribute to knowledge in this area by s

subgroups of children and the interactions am

many different exposure and outcome factors. 

Does a vitamin-rich diet help decrease asth

risk? Data from CDC’s third National Health a

Nutrition Examination Survey (1988–1994) n

that children exposed to second-hand smoke 

exacerbations of asthma.76 Although further r

is required, there is epidemiological data to su

that dietary antioxidant supplements (e.g., be

carotene, selenium, Vitamin C) might reduce 

prevalence and severity of asthma in some 

children.77, 78 The National Children’s Study ca

employ multidisciplinary capacities in evalua

children’s diets, use of nutritional supplemen

exposure to second-hand smoke. Antioxidant 

can be tested through serum samples and, in 

cases, breath analyzers. 

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cohort demonstrated that impaired glucose tolerancethe early warning sign of impending diabetes

is associated with overweight and obesity in children.85The National Children’s Study can follow up on th

finding in a much larger population of children, evaluating the links between and among biology, 

psychosocial environments, diet, exercise, and obesity. 

Addressing Obesity, Diabetes, and 

Physical Development 

The National Children’s Study will address several 

research questions in this area. Some examples include: 

Does impaired maternal glucose metabolism 

during pregnancy cause overweight in children? 

A number of factors affect glucose metabolism in 

pregnancy, including maternal nutrition, physical 

activity, and infection—and the timing of such factors 

during gestation may be critically important. This 

question is especially relevant because more women of 

reproductive age are overweight, a known risk factor 

for gestational diabetes, and preliminary evidence 

suggests a relationship between maternal glucose 

metabolism and childhood obesity.86 The National 

Children’s Study will measure glucose tolerance during 

pregnancy and will assess children’s weight several 

times through age 21 to draw conclusions. A 

positive link could establish the need for increased 

emphasis on weight control before pregnancy— 

and for greater glucose control during pregnancy. 

Does breastfeeding reduce the risk of obesity? Is 

the protective effect of breastfeeding due to breast milk 

itself, or to differences in feeding practices between 

breast and formula-fed infants? If breastfeeding helps 

to prevent subsequent obesity, it would be one of the 

few simple obesity-prevention measures available.87 

The National Children’s Study can collect informati

about breastfeeding practices, obtain samples of bre

milk, and assess body size multiple times during 

childhood and adolescence to answer this question

How do diets low in fiber and whole grains, but 

high in refined sugars, increase risk for obesity a

diabetes? Children’s weights and measures of food 

intake can be assessed throughout the Study to ans

this question. Because of the study size, the multipl

subgroups of children, and varied diets, the Study h

a unique opportunity to identify aspects of children

diets that contribute to weight control and could ha

a substantial impact on dietary recommendations. 

Does the physical environment, such as sidewal

proximity to parks, and a safe neighborhood, he

prevent obesity? An improved understanding of 

“built environment” that influences physical activ

and overweight will assist planners in designing 

towns and neighborhoods that promote public 

health. In the National Children’s Study, the 

characteristics of children’s homes and environme

will be assessed and physical activity levels will b

determined through interviews, activity diaries, a

measurements of children’s body weights. 

Page 42
 
Exposures to toxic materials are known to affect a range of cognitive, sensory, and motor function

in children, as well as their social and emotional development.89 Conditions believed to be affected b

environmental factors include ADHD, autism spectrum disorders (ASDs), and mental retardation

The National Children’s Study has a unique opportunity to gather information about these and 

other conditions to assess linkages with environmental influences. 

Addressing Child Development and 

Mental Health 

The Study will examine numerous research 

questions in the areas of child behavior, learning, 

neurodevelopment, mental health, and 

developmental disorders, including: 

How does routine low-level pesticide exposure 

interact with genes to affect neurobehavioral and 

cognitive performance? The general adult 

population has had widespread exposure to 

pesticides, as reflected by urine tests conducted in 

previous studies.90 Children often have greater 

exposure than adults due to increased contact with 

the ground and their tendency to put objects in their 

mouths. The Study can assess both in utero and 

postnatal exposures to pesticides with neurobehavioral and cognitive examinations during infancy 

and childhood. Linkage to school records may also 

allow for the assessment of cognitive function. 

Are early exposures to neurotoxicants—as 

and alcohol are known to be in utero—assoc

with developmental and mental health anom

Neurotoxicant exposure has been linked to

increased aggression, delinquency, hyperactiv

impulsivity, poor socialization skills, and gene

difficulty with cognitive and intellectual activ

The National Children’s Study will monitor

relationships between known neurotoxicant 

exposures and subsequent behavioral and cog

changes, including interactions of exposures 

multiple agents, as well as contributing eleme

that may be harmful as well as helpful to

neurodevelopment, such as family dynamics,

caregiver supervision, and classroom environ

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Study will bring genetic research to a new magnitude of utility and insight. 

Addressing Genetics 

The National Children’s Study can employ the tools 

of molecular biology to investigate the role of genetic 

variation in disease, as well as disease-related 

vulnerabilities and predispositions in individuals and 

groups. The ability to assess these points across two 

decades and among 100,000 individuals at various 

ages presents a unique opportunity to generate new 

data and innovative health care strategies. 

In what ways do environmental factors intersec

with genes? National Children’s Study investigato

will use the latest knowledge about “target genes,” 

suspected to be involved in the development of 

certain diseases, to develop broad-based conclusio

about gene-environment interactions in large 

populations. The sequencing of the human genom

has made this research possible by generating 

massive sets of data that allow scientists to study t

links between genes and the environment. 

With the completion of the human 

genome sequence in 2003, there is an 

extraordinary opportunity to analyze 

the interactions between genetic and 

environmental factors that affect health

Page 44 
Pag
that contribute to child health problems.Causeandeffect relationships between physical 

environments and health, however, have been difficult to quantify and study in an orderly manner. 

Addressing the Physical Environment Does household mold exposure in the first year 

The National Children’s Study can evaluate multiple life lead to asthma? A recent study confirmed a 

aspects of built and physical environments through strong association between the presence of mold 

a variety of direct sampling and survey tools, homes and apartments of newborns with the 

including measurement of indoor exposures related development of asthma.94 (The same study noted 

to dust mites, cockroaches, mold, building more modest, but still positive, association betwe

materials, gas and wood-burning stoves, and pets. cockroach infestation in homes of newborns and 

Potential research questions include: subsequent childhood asthma.) The National 

Do aspects of the physical environment, such as Children’s Study can act on this compelling 

preliminary evidence by designing larger studies housing quality and neighborhood and community 

to investigate the relationships between built conditions, affect child health and development? 

environments and allergens; toxins and the This question opens the door for evaluating 

appearance of asthma; and other respiratory relationships between inadequate housing, schools, 

syndromes in children. and economically challenged communities and the 

presence of diseases, developmental disabilities, 

impacted school performance, and signs of chronic 

psychological stress. Inadequate housing is also 

often associated with the presence of airborne lead 

(or remaining lead paint), mold and mold toxins, 

and increased indoor pesticide use—all of which 

can be measured over time by National Children’s 

Study investigators.93 

Page 46
 
Although science has linked some chemicals to nervous system deficits, greater research is neede

monitor exposures and identify factors that may be tied to unexplained birth defects and 

developmental disabilities. Likewise, additional research may find that some chemicals are harmle

creating no cause for concern. 

Addressing the Chemical Environment What are the health effects associated with 

The National Children’s Study can monitor complex low-level exposures? Toxicants emi

exposures to neurotoxicants, contributing vital data into the environment at very low levels presen

to information produced by birth registries and toxic special challenge. These agents can be difficu

chemical surveys and reporting systems. Critically detect or to fully distinguish from other 

important is the Study’s ability to analyze genetic environmental factors. The National Children

susceptibility to environmental “triggers” that may Study can conduct sophisticated environmen

initiate gene-based nervous system damage. Some ambient air measurements and can analyze bu

possible research questions include: materials. These data, coupled with surveys a

What happens to the human organism after long questionnaires, will generate insight into caus

associations between low-level exposures and periods of low-dose exposure to chemicals, 

diseases or conditions, if any, and help to esta

pesticides, and herbicides? The National Children’s 

threshold exposure levels as well as the intera

Study can assess chemical exposures over time 

effects of combinations of exposures. through the sampling, tracking, and comparison 

of umbilical cord and infant and maternal blood 

samples. Longitudinal and comparative data can 

reflect variations in exposures across time and 

geographical locations. Other data-gathering 

techniques might include maternal questionnaires 

and software programs designed to rapidly detect 

significant correlations among regions, toxicants, 

and rates of disability. 

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and social influences. 

Addressing the Psychosocial Environment 

Using surveys, medical histories, housing records, 

direct interviews, and sociological data, the National 

Children’s Study can link psychosocial environments 

to clinical, genetic, and other information that may 

lead to improved strategies for intervention and care 

on many levels, including medical, public, and social 

services. Potential research questions may include: 

How do social environmental factors contribute to 

diseases? Many studies have been published over 

the last decades suggesting that personal factors 

(e.g., school, family, relationships) can influence an 

array of physical symptoms and adverse behavioral 

and developmental changes. Most of these studies 

were limited by cohort size, period of time, or 

regions in which the research took place. Using 

various psychosocial measures in combination with 

clinical data, the National Children’s Study can 

employ the advantages of a large participant 

population and greater time to help address this 

broad question. 

Does chronic exposure to urban violence 

exacerbate asthma? Research completed in 2001 

suggests that exposure to violence exacerbates 

asthma. In a small study of children in one innercity neighborhood, there was a temporal associati

between exposure to violence and flares of asthm

symptoms (e.g., wheezing, coughing).98 The 

National Children’s Study might further this 

investigation on a much broader scale by merging 

data on the incidence of violent episodes with 

patterns of asthma, based on family diaries and 

hospital and clinic measures. 

How do differences in the social environment 

across many complex factors produce health 

disparities between urban and rural residing 

children? Lifestyle, occupation, and behavioral 

patterns vary among children living in cities versu

rural areas. The National Children’s Study can 

examine the role these factors might play in the he

and disease outcomes those groups experience. 

Page 48
 
 

remain about the longterm implications of immune damage sustained early in life.The debate go

to the heart of a significant area of research for the National Children’s Study. 

Addressing the Biologic Environment 

The National Children’s Study can evaluate the 

biologic environment by intersecting data culled 

from medical records (e.g., incidence of infectious 

diseases among participants at different ages and in 

specific locations), as well as from on-site sampling 

of ambient air that is tested for the presence of bioallergens. Other assessments can include vector 

sampling (e.g., shared surfaces in homes and public 

areas), blood cultures and throat swabs for 

microbiologic assessment, and inflammatory 

biomarkers (e.g., erythrocyte sedimentation rate, 

C-reactive protein levels). 

Do chemical toxicants consistently suppress 

immunity and facilitate infections? The National 

Children’s Study can measure environmental toxicant 

levels in specific locations and compare that data 

against the incidence of a variety of infectious diseases, 

including immune-mediated entities such as asthma, 

hypersensitivity reactions, and chronic dermatitis. The 

Study can also use genetic methods to monitor immune 

system and inflammatory changes at the molecular 

level, in concert with known chemical exposures. 

Do specific infections incite heart disease? The role 

of inflammation in heart disease is well-established 

in adults, but a growing volume of data supports the 

possibility that infections early in life may also play a 

role. The National Children’s Study can investigate 

the linkages between specific common pathogens and 

evidence of heart and vascular disease early in life. It 

also can track individuals across time to assess the 

progression of disease, from the earliest mole

changes to more overt signs and symptoms. A

the way, data on diet and exercise regimens c

provide additional information about the way

which heart disease is initiated and ameliorat

Does prenatal infection and inflammation in

risk of cerebral palsy and autism spectrum dis

Previous studies have shown that exposure to 

prenatal infection or inflammation may increa

of cerebral palsy.100 Less data are available on 

possible link to ASDs. The Study can assess p

infection and inflammation through the patholo

microbiologic evaluation of placentas. Assessm

the neurodevelopment of children can includ

diagnostic algorithms that identify all cases of 

palsy and ASDs. A review of medical and sch

records may also help identify cases of these dis

What factors during pregnancy are associat

increased risk of schizophrenia? Because it i

known that schizophrenia is related to geneti

predisposition in only half of all cases, the Stu

well-positioned to investigate other causes. Pr

exposure to infectious agents, such as herpes si

type 2 (genital herpes), has long been thought 

have a link to the development of schizophren

National Children’s Study will consider the timin

infection in relation to birth by collecting mult

blood samples during pregnancy. If exposure t

certain infections is associated with schizophren

better understanding, detection, and managem

the disorder will be possible. 

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Weighing 25 percent of 

its eventual adult weight, 

the brain of a newborn 

is still developing the 

synapses and neurons 

that enable the senses 

and memory. 

Birth 

After months of preparation 

and anticipation, the child is 

welcomed into the world. 

He joins his parents as 

participants in the National 

Children’s Study and 

important data are collected 

about him. 

Year 1: 

Taking Steps 

Around his first 

birthday, he is taking 

his first steps. 

A great adventure 

for the child, 

walking is a motor 

skill that requires 

coordination, 

balance,and 

practice. 

Page 50 

Age 1 

The first results from 

the National Children’s 

Study are available and 

will provide insight on 

some outcomes related 

to events during 

pregnancy (e.g., 

maternal nutrition 

during pregnancy 

and prenatal care). 

During this stage 

of development, 

researchers can check 

an infant’s respiratory 

and immune systems to 

detect early markers 

of asthma. 

Year 3: 

Who am I? 

Although still a 

toddler,a three-yearold is developing 

a healthy sense of 

self-esteem and a 

sense of empathy for 

others.The critical 

development of the 

brain continues as 

her vocabulary 

grows and curiosity 

develops. 

Age 3 

The toddler is developing 

communication skills 

and exploring the 

environment around 

him.The early clues as 

to the development of 

autism can be detected 

by this age (if not 

earlier). 

She ties her own 

shoelaces, writes her 

own name, knows right 

from left, and relies on 

her 10,000-word 

vocabulary.Around 

the age of five, she 

has developed a hand 

preference and is 

seeking knowledge 

from her environment. 

Age 5 

The school environment 

brings new opportunities 

for intellectual and social 

development.The 

researchers and scientists 

of the National Children’s 

Study can measure ability 

to learn and check for 

learning disabilities. 

the ages of seven and 

eight.Both boys and 

girls often start to 

join organized games 

and activities such 

as soccer, basketball, 

or dance. 

Age 7 

The child i

understand 

special invo

in the Nati

Children’s 

Year 10: 

Humor 

Laugh and a 

laughs with 

the age of 

can underst

humor,met

and wit.Als

switch the f

conversatio

another pe

needs or m
Age 10 

How the child 

interacts with peers in 

social and educational 

settings will tell 

researchers something 

about his social 

development thus far. 

new social setting of 

high school, he may 

be concerned with 

appearance and gaining 

the approval of friends 

and classmates. 

Age 13 

The child’s environment 

can enhance or impede 

her physical development. 

Researchers will know if 

puberty is on track and 

how diet,exercise,and 

the built environment 

are affecting growth. 

developed a sense of 

responsibility and a sense 

of identity. 

Age 16 

The National Children’s 

Study research team can 

see evidence of the teen’s 

support systems and 

capabilities to make good 

personal choices. 

adulthood

its own d

milestone

challenge

Age 21 

The youn

graduated 

school an

establish 

herself,in

her paren

making d

impact he

career,pe

well being

A Child’s Development as a Study Par

Pag
Page 52
 
CHALLENGES OF 

THE NATIONAL 

CHILDREN’S STUDY 

Pag
Laying the 

Groundwork: 

Pilot Studies and 

Discussion Groups 

Page 54
 
The National Children’s Study has already initiated a number o

preliminary research efforts that will allow investigators to 

understand where challenges lie and what obstacles might be 

encountered. Already producing useful data, these efforts ensu

that the Study identifies the best and most cost-efficient metho

and practices for meeting complex scientific goals. 

For more than three years, scientists from many disciplines, inclu

medicine, environmental science, chemistry, biostatistics, social a

behavioral sciences, and human growth and development, have 

worked to build a foundation for the National Children’s Study. T

efforts, collectively known as “pilot studies,” range from evaluatin

the possibility of recruiting primary care physicians as local Study 

researchers, to finding inexpensive and unobtrusive techniques fo

measuring various exposures in homes and schools, to identifyin

best ways for collecting and storing specimens, to ensuring accur

in the data from numerous Study sites within the United States. 

Pag
Among the pilot efforts are exposure studies, which 

seek to predict the where, when, and why of 

environmental exposures, along with the different 

pathways of those exposures. For example, because 

infants interact with their environment differently 

child development. 

Study design pilot studies explore different ways to 

conduct a study, such as optimal approaches to 

involving communities and recruiting participant

Page 56 Page 56 
multidisciplinary collaborations in many of the 

Study theme areas simultaneously, and, along the 

way, offer exceptional potential to identify new and 

emerging technologies of use to the National 

Children’s Study. Such studies also lay the 

groundwork for a children’s environmental health 

research database of substantial utility and range. 

This is a once-in-a-lifetime opportunity. 

It will shape the research agenda for the 

next generation. 

Robert Chapin, Ph.D., head, Investigative 

Developmental Toxicology Lab, 

Pfizer Pharmaceuticals 

In the context of these strategies and techniques, 

experts from various disciplines relevant to the 

Study have assembled as working groups to discuss 

the scientific, medical, and ethical issues pertinent to 

a study of this magnitude. Numerous analytical papers 

have been or are now being prepared, looking at the 

capacities. The National Childrens Study pilot 

are preparing for the road ahead, laying critic

groundwork to ensure that the Study reaches 

goals and offers a substantive return on inves

in terms of health, knowledge, and new capab

Pag
Planned Approaches to 

Study Challenges 

Page 58
 
from clinical research because the risks were considered too gr

But now the nation realizes that not including children in resea

poses even greater risks to public health and safety. If children 

at the highest risk, they need and deserve our best research effo

The National Children’s Study is a response to the need for new 

knowledge in the area of environmental exposures in children. 

what are the issues surrounding recruitment of children before b

long before they can express an opinion about their participati

There are established precedents for the safe and responsible 

recruitment of children, and institutional regulations govern 

ethical conduct of research involving children. National Childr

Study planners are committed to making every effort to ensure 

participants’ safety. 

Pag
that emphasizes clarity and accessibility. Informational 

materials, Web sites, informed consent forms, and 

possibly interactive consent computer programs will 

be made available at appropriate reading levels and 

in the languages spoken by the families involved. 

The families of participating children (and, 

eventually, the children themselves) are the pivotal 

Study partners. They will be encouraged to provide 

ongoing feedback on their experiences in the Study. 

Their questions, problems, and issues will be critical 

to creating the balance that will guide the conduct of 

the National Children’s Study, ensure responsible 

and responsive Study management, and make this a 

truly unprecedented national research effort. 

PARTICIPANT CONFIDENTIALITY 

In discussion groups conducted during the Study’s 

planning stage, expectant and current parents and 

other stakeholders consistently raised privacy as a 

key issue. Community leaders and health care 

providers echoed these concerns. All believe that 

participants must clearly understand the Study’s 

To address these concerns, the National Children

Study will devote careful attention to personal 

privacy. Among other protections, DHHS recently 

released new guidelines under the Health Insuran

Portability and Accountability Act of 1996 to pro

the confidentiality of individuals’ medical records

which the National Children’s Study program staf

will follow. Study coordinators will also construct 

the Study’s databases to ensure the protection of 

privacy (e.g., encrypted sites and secure data entr

forms) and will proactively address security issue

(e.g., protecting data from outside attack). 

The National Children’s Study also will rely on 

institutional review boards to review ethics safegua

and participant protections. The Study may assem

an independent panel to provide an extra level of 

review in managing issues related to confidentiali

PROTECTING PARTICIPANTS 

(INFORMED CONSENT) 

A critical factor in mounting such a broad-based 

research effort hinges on how individuals will giv

Page 60
 

The National Children’s Study is a national response to the 

need for new knowledge in the area of environmental 

exposures. If children are our most at-risk population in this 

arena, they need and deserve our best research efforts. 
and well being of individuals participating in 

that research. 

permission for their children’s participation in the 

National Children’s Study. 

Informed consent is the mechanism by which any 

individual choosing to participate in research does 

so independently and on the basis of open 

communication about a study’s aims, goals, and 

potential risks and benefits. Informed consent also 

provides a potential participant with adequate time 

to reflect before making a decision. It is fully 

embraced by the National Children’s Study and 

supported by rigorous federal guidelines for 

investigators and individuals that govern the ethical 

conduct of research, especially efforts involving 

pregnant women and children. 

Within this context, the following series of 

related concepts drive the Study’s approach to 

informed consent: 

■ Informed consent is fundamental to the Study. 

■ The risk posed by participation in the Study is 

expected to be minimal. 

■ Additional safeguards will be in place to protect 

the rights and interests of child participants. 

■ Because participants will reflect the diverse 

nature of the United States, every effort will be 

made to provide useful Study information 

understandable terms and appropriate lang

■ When Study participants reach a predeterm

age, they will have the opportunity to activ

affirm their parents’ endorsement of their 

participation in the Study. 

PARTICIPANT RECRUITMENT 

Recruiting and retaining 100,000 participants 

unquestionably the greatest challenge for the 

National Children’s Study. Because the Study 

begin by following fetal health, Study coordin

must enroll pregnant women early enough to m

their fetuses as well as their diets and other fa

Enrolling such a large number of participants

from every corner of the country and virtually 

every racial, ethnic, and socioeconomic group

will require a coordinated effort of research st

health care providers, and intermediaries who 

can reach and inform families about the Stud

Recruitment is slated to begin around 2006, a

the National Children’s Study is launched, an

last through 2011. 

Study information materials must emphasize b

while allaying potential concerns. Study coord

are designing a strategy that meets these need

Pag
recruitment goals and providing information for the 

population(s) they serve. 

Study planners anticipate that intense, local 

grassroots campaigns will yield the greatest 

recruitment for each site. Local campaigns will 

promote the formation of community partnerships; 

build relationships with area obstetricians and other 

health care providers; and direct outreach to 

parenting groups, religious and community 

institutions, and other organizations offering health 

information and support to families. Previous 

studies have demonstrated that endorsement and 

referral from trusted community leaders is a 

significant factor in encouraging study participation. 

PARTICIPANT RETENTION 

The task of keeping track of 100,000 families, 

through changes in family structure, new residences, 

and departures for college or work, is formidable. 

The National Children’s Study is developing a 

retention strategy that builds on its recruitment 

efforts and draws from past study successes. Because 

it is such a crucial aspect of the Study, retention is 

community leaders will be critical to the 

success of the recruitment efforts. 

According to published reports on previous 

longitudinal studies, a critical factor in keeping 

participants “on board” is the bond they develop 

with Study staff and fellow participants. That Stud

investigators and support staff, in particular, 

personally care about the children and families 

involved is a powerful motivator toward continue

participation. Building on the relationships betwe

participants and Study staff, the National Childre

Study will seek to create a community of “Nation

Children’s Study Families” in which each site—as 

well as the entire community—recognizes and 

celebrates the role of participants. Some tools and 

activities to promote connection and cohesion 

among participants may include newsletters (both 

electronic and print), interactive Web sites for the 

children, periodic get-togethers, public 

presentations, and birthday greetings. As in most 

studies of this kind, participants will receive 

incentives for their continued participation. 

Page 62
 

Study coordinators will need to be creative and flexible in 

developing ways to keep 100,000 families engaged in the Study 

through its completion. 
s
 

Social Services 

Departments 

Schools 

Parents’ 

Organizations 

Youth 

Organizations 

Gyms & 

Recreational 

Centers 

Health 

Departments

Local 

Places of 

Worship 

Men’s & 

Women’s 

Organizations

City Planning 

Departments 

Local 

Governments 

P

Local Civic 

or Faith 

Leaders 

Community 

Advisory 

Boards 

YMCAs 

YWCAs 

Personal 

Support 

Networks 

Study
 

articipant

Children &
 

Parents
 

Community 

Health 

Centers 

Hospitals 

Friends 

Local 

Media & 

Information 

Services 

Local 

Chambers o

Commerce

Community 

Health Fairs 

Diabetes/ 

Asthma 

Clinics 

Radio & 

Intern

Work S

Restaur

Newspapers & 

Community 

Newsletters 

Grocery 

Stores 

f 

Colleges & 

Universities 

Pharmacies 

NATIONAL CHILDREN’S STUDY SPONSORS 

■ U.S. Department of Health and Human Services 

— National Institutes of Health 

— Centers for Disease Control and Prevention 

■ U.S. Environmental Protection Agency 

Pag
Page 64
 
THE NATIONAL 

CHILDREN’S STUDY 

Pag
The Health and 

Economic Benefits 

of the National 

Children’s Study 

Page 66
 
, , 

and substantive results. 

The health and medical burdens we face are complex and 

widespread. We know, for example, that children bear an incre

vulnerability to various types of exposures; that they are not 

simply “small adults”; and that they do not have the same imm

protection or detoxification capacities as adults. And, because t

are children, they have little or no ability to protect themselves 

abuse or neglect situations. 

The urgency and significance of the challenges to child health 

clear, but there are scientific barriers to address. Much of the 

evidence to date establishes links between specific exposures a

specific outcomes. And even though many of these relationship

are undeniable, considerable work remains to understand the 

subtle molecular and genetic mechanisms involved. 

Pag
well beyond the investment of creating and 

maintaining the Study. 

With its emphasis on multiple environmental 

exposures and health outcomes across more than 

two decades, the National Children’s Study will 

combine scientific efficiency with cost-effectiveness. 

Evaluating data exposures in relation to genetic 

predispositions to health and disease among 

I am convinced that this study, if successful

will be remembered for years to come 

as one of the most important scientific 

enterprises ever started regarding 

children’s health. 

Fernando Martinez, M.D., professor, Pediatrics, 

University of Arizona 

Page 68 
Pag
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