Effects of Early Nutrition on Growth

Not Applicable

Completed

• Conditions: Infant Newborn
• Interventions: Other: Investigational infant formula; Other: Milk based standard infant formula; Other: Human Milk

• Registration Number: NCT01300000
• Lead Sponsor: Abbott Nutrition

Brief Summary

The primary objective of the study is to compare the growth of infants fed standard infant formula with infants fed a reduced calorie and protein formula.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2011-02-17
• Study First Submitted QC: 2011-02-17
• Study First Posted: 2011-02-21
• Primary Completion: 2014-09
• Study Completion: 2016-08
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 649

Inclusion Criteria

• good health
• singleton birth with gestational age 37-42 weeks
• infant's birth weight >or = to 2500 grams
• exclusive breastfeeding or exclusively formula feeding
• within a defined geographical boundary
• mother has no problems communicating in English

Exclusion Criteria

• adverse maternal, fetal or infant medical history
• congenital disease or malformation affecting growth or development
• illness or social problems in mother or infant
• temporary residents

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Milk based investigational infant formula	Investigational infant formula	ad lib
Milk based standard infant formula	Milk based standard infant formula	ad lib
Human Milk	Human Milk	ad lib

Primary Outcome Measures

Name	Time	Method
Weight gain	1- 365 days

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal tolerance	1-365 days
Infant Anthropometrics	1 - 365 days; 24 months

Trial Locations

Locations (1)

MRC Childhood Nutrition Research Center, Institute of Child Health; 🇬🇧 London, United Kingdom