Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula

Completed

• Conditions: Healthy
• Interventions: Other: Study formula feeding; Other: Human milk feeding; Other: Mixed feeding

• Registration Number: NCT01370967
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Study Timeline

• Study First Submitted: 2011-06-08
• Study First Submitted QC: 2011-06-08
• Study First Posted: 2011-06-10
• Study Start: 2011-07
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-23
• Last Update Posted: 2013-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 460

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study formula-fed only	Study formula feeding	-
Human milk-fed only	Human milk feeding	-
Mixed-fed using study formula only	Mixed feeding	-

Primary Outcome Measures

Name	Time	Method
Infant stool consistency and frequency (assessed using a 3-day stool diary)	day 45

Secondary Outcome Measures

Name	Time	Method
Infant gastrointestinal tolerance (assessed using a validated, interviewer-assisted parent questionnaire)	day 48
Infant and parent health-related quality of life (assessed using validated parent questionnaires)	day 48

Trial Locations

Locations (24)

Children's Hospital of Chongqing Medical University; 🇨🇳 Yuzhong, Chongqing, China

The Third Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

Zhongshan Bo'ai Hospital; 🇨🇳 Zhongshan, Guangdong, China

West China Second University Hospital, SCU; 🇨🇳 Chengdu, Sichuan, China

The First Affiliated Hospital, Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China

Guangzhou Women and Children's Medical Center; 🇨🇳 Guangzhou, Guangdong, China

Suzhou Municipal Hospital; 🇨🇳 Suzhou, Jiangsu, China

Ningbo Yinzhou People's Hospital; 🇨🇳 Ningbo, Zhejiang, China

Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, China

Zhu Jiang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China

Beijing Haidian Maternal&Child Health Hospital; 🇨🇳 Haidian District, Beijing, China

The 306th Hospital of PLA; 🇨🇳 Chaoyang District, Beijing, China

Dongguan People's Hospital; 🇨🇳 Dongguan City, Guangdong, China

Changsha Hospital for Maternal&Child Health Care; 🇨🇳 Changsha, Hunan, China

Shantou Central Hospital; 🇨🇳 Shantou, Guangdong, China

Nanjing Maternity and Child Health Care Hospital; 🇨🇳 Nanjing, Jiangsu, China

Maternity and Child Health Care Hospital in Jiangsu Province; 🇨🇳 Nanjing, Jiangsu, China

Beijing Obstetrics Gynecology Hospital; 🇨🇳 Beijing, China

Chengdu Women & Children Center Hospital; 🇨🇳 Chengdu, Sichuan, China

Children's Hospital of Fudan University; 🇨🇳 Shanghai, China

Tianjin First Center Hospital; 🇨🇳 Nankai, Tianjin, China

Nanfang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China

Hangzhou First People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China

Peking University First Hospital; 🇨🇳 Beijing, China