Clinical trial NCT01370967: Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula
Official title: Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula: A Prospective, Observational Cohort Study In China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: infant
term birth
human milk
infant formula
breast feeding
bottle feeding
gastrointestinal tract
quality of life
infant development
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2011-06-10
Enrollment: 460
Sex: ALL
Minimum age (years): 35
Maximum age (years): 49
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy term infants aged approximately 42 days (range 35 - 49 days) who are brought to the health clinic for their first normally-scheduled well-baby visit (i.e. typically age 42 days in China).

Brief summary: The purpose of this study is to assess stool consistency, in combination with additional health-related parameters including gastrointestinal tolerance and health-related quality of life, in a large sample of Chinese infants. We will also assess the timing of, frequency, and reasons for changes in the choice of formula or method of feeding among infants in this sample, as well as incidence of common infant illness and associated healthcare usage. Anthropometric measures and the frequency and duration of physician- and parent-reported gastrointestinal and other adverse events will be evaluated.

Detailed description: Parents / legally acceptable representatives of eligible infants will be invited to volunteer.

Eligibility criteria: Inclusion Criteria:

* Healthy, term (37-42 weeks gestation), singleton infant at birth.
* Post-natal age between 35 and 49 days (date of birth = day 0) at time of study entry.
* At enrollment, weight-for-age ≥ 5th and ≤ 95th percentile according to World Health Organization growth tables / charts.

Exclusion Criteria:

* Infants who are consuming any types/brands of formula other than the new study formula (either exclusively or in a mixed feeding regimen) at time of study enrollment.
* Suspected or documented severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results, and in the judgment of the investigator, would make the infant inappropriate for entry into the study.

Primary outcomes:
measure: Infant stool consistency and frequency (assessed using a 3-day stool diary)
timeFrame: Baseline
measure: Infant stool consistency and frequency (assessed using a 3-day stool diary)
timeFrame: day 15
measure: Infant stool consistency and frequency (assessed using a 3-day stool diary)
timeFrame: day 30
measure: Infant stool consistency and frequency (assessed using a 3-day stool diary)
timeFrame: day 45
Secondary outcomes:
measure: Infant gastrointestinal tolerance (assessed using a validated, interviewer-assisted parent questionnaire)
timeFrame: Baseline
measure: Infant gastrointestinal tolerance (assessed using a validated, interviewer-assisted parent questionnaire)
timeFrame: day 18
measure: Infant gastrointestinal tolerance (assessed using a validated, interviewer-assisted parent questionnaire)
timeFrame: day 48
measure: Infant and parent health-related quality of life (assessed using validated parent questionnaires)
timeFrame: Baseline
measure: Infant and parent health-related quality of life (assessed using validated parent questionnaires)
timeFrame: day 48
Other outcomes:
Locations:
city: Chaoyang District
country: China
facility: The 306th Hospital of PLA
state: Beijing
city: Haidian District
country: China
facility: Beijing Haidian Maternal&Child Health Hospital
state: Beijing
city: Yuzhong
country: China
facility: Children's Hospital of Chongqing Medical University
state: Chongqing
city: Dongguan City
country: China
facility: Dongguan People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Women and Children's Medical Center
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Zhu Jiang Hospital of Southern Medical University
state: Guangdong
city: Shantou
country: China
facility: Shantou Central Hospital
state: Guangdong
city: Zhongshan
country: China
facility: Zhongshan Bo'ai Hospital
state: Guangdong
city: Changsha
country: China
facility: Changsha Hospital for Maternal&Child Health Care
state: Hunan
city: Nanjing
country: China
facility: Maternity and Child Health Care Hospital in Jiangsu Province
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Maternity and Child Health Care Hospital
state: Jiangsu
city: Suzhou
country: China
facility: Suzhou Municipal Hospital
state: Jiangsu
city: Chengdu
country: China
facility: Chengdu Women & Children Center Hospital
state: Sichuan
city: Chengdu
country: China
facility: West China Second University Hospital, SCU
state: Sichuan
city: Nankai
country: China
facility: Tianjin First Center Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Yinzhou People's Hospital
state: Zhejiang
city: Beijing
country: China
facility: Beijing Obstetrics Gynecology Hospital
city: Beijing
country: China
facility: Peking University First Hospital
city: Shanghai
country: China
facility: Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
Study officials:
References:
citation: Hays NP, Mao M, Zhang L, Ge J, Northington R, Yao M, Volger S. Infant feeding and health-related quality of life in healthy Chinese infants: results from a prospective, observational cohort study. Health Qual Life Outcomes. 2016 Aug 8;14(1):116. doi: 10.1186/s12955-016-0518-3.