Clinical trial NCT01793116: Generic Database of Moderate Preterm Infants
Official title: Time Limited Observational Study of the Moderately Preterm Infant (29 0/7 - 33 6/7 Weeks)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant, Newborn
Infant, Moderate Preterm
Keywords: NICHD Neonatal Research Network
Moderately Preterm
Lead sponsor: NICHD Neonatal Research Network
Sponsor class: NETWORK
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2013-02-15
Enrollment: 7057
Sex: ALL
Minimum age (years): 29
Maximum age (years): 33
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Moderately preterm infants born at 29 0/7 weeks to 33 6/7 weeks-both inborn and outborn but admitted prior to 72 hours at NRN centers will be included in this study.

Brief summary: This is a registry of moderate preterm infants, born alive at 29-33 weeks gestational age, in NICHD Neonatal Research Network (NRN) centers. The registry collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The information collected is not specific to a disease or treatment (i.e., it is "generic"). Data are analyzed to find associations and trends between baseline information, treatments, and infant outcome, and to develop future NRN trials.

Detailed description: The Moderate Preterm Registry is a registry of moderate preterm infants (29-33 weeks gestational age) born alive in NICHD Neonatal Research Network (NRN) centers. The purpose is to collect baseline and outcome data in a uniform manner on a cohort of infants.

The registry collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The information collected is not specific to a disease or treatment (i.e., it is "generic"). Baseline data is collected soon after admission to the NICU; outcome data is collected at the time of death or discharge from the hospital. The data collected includes information on:

* Demographics of mother and infant
* Mother's health (e.g., pregnancy history and complications)
* Labor and deliver (e.g., rupture of the membranes, steroids and antibiotics given, mode of delivery)
* Infant's health (gestational age, Apgar scores, weight, length, delivery room resuscitation, respiratory support, etc.)
* Infant's medical outcome (heart, lung, nervous system, gastrointestinal system, hearing, and vision, known infections, and major malformations/syndromes, and mortality or number of days hospitalized).

These data are used: to examine associations between baseline characteristics, treatments, and outcomes; to track trends in incidences of disease and effectiveness of therapies; and to identify questions requiring additional in-depth research.

Informed Consent: As required by local IRBs.

Eligibility criteria: Inclusion Criteria:

* Gestational age 29-33 weeks
* Inborn infants and outborn infants admitted by 72 hours.

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of infants born moderately preterm
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: University of California - Los Angeles
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Durham
country: United States
facility: RTI International
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Case Western Reserve University, Rainbow Babies and Children's Hospital
state: Ohio
city: Columbus
country: United States
facility: Research Institute at Nationwide Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Univeristy of Pennsylvania
state: Pennsylvania
city: Providence
country: United States
facility: Brown University, Women & Infants Hospital of Rhode Island
state: Rhode Island
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: Brown University, Women & Infants Hospital of Rhode Island
name: Abbot R Laptook, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Case Western Reserve University, Rainbow Babies and Children's Hospital
name: Michele C Walsh, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Ronald N Goldberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Barbara J Stoll, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University
name: Brenda B Poindexter, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: RTI International
name: Abhik Das, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Krisa P Van Meurs, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Medical Center, Cincinnati
name: Kurt Schibler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingha
name: Waldemar Carlo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa
name: Edward F Bell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of New Mexico
name: Kristi L Watterberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas, Southwestern Medical Center at Dallas
name: Pablo J Sanchez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center, Houston
name: Kathleen A Kennedy, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Wayne State University
name: Seetha Shankaran, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Abbot R Laptook, MD Study Principal Investigator Brown University, Women & Infants Hospital of Rhode Island Michele C Walsh, MD MS Study Principal Investigator Case Western Reserve University, Rainbow Babies and Children's Hospital Ronald N Goldberg,
name: William Truog, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Barbara Schmidt, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester
name: Carl D'Angio, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Uday Devaskar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Institute at Nationwide Children's Hospital
name: Leif Nelin, MD
role: PRINCIPAL_INVESTIGATOR
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