Effects of Early Nutrition on Growth

Abbott Nutrition649 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

649

Conditions

Infant Newborn

Interventions

Human MilkOTHER

ad lib

Investigational infant formulaOTHER

ad lib

Milk based standard infant formulaOTHER

ad lib

Eligibility

Sex: ALLMin age: 1 MinuteMax age: 24 HoursHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

MRC Childhood Nutrition Research Center, Institute of Child Health

London, United Kingdom

Outcomes

Primary Outcomes

Weight gain

Time frame: 1- 365 days

Secondary Outcomes

Gastrointestinal tolerance

Time frame: 1-365 days

Infant Anthropometrics

Time frame: 1 - 365 days; 24 months

Data from ClinicalTrials.gov

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