Effects of Early Nutrition on Growth

NCT ID: NCT01300000

Last Updated: 2017-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

649 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2016-08-31

Brief Summary

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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

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Conditions

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Infant Newborn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Human Milk

ad lib

Group Type ACTIVE_COMPARATOR

Human Milk

Intervention Type OTHER

ad lib

Milk based standard infant formula

ad lib

Group Type ACTIVE_COMPARATOR

Milk based standard infant formula

Intervention Type OTHER

ad lib

Milk based investigational infant formula

ad lib

Group Type EXPERIMENTAL

Investigational infant formula

Intervention Type OTHER

ad lib

Interventions

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Human Milk

ad lib

Intervention Type OTHER

Investigational infant formula

ad lib

Intervention Type OTHER

Milk based standard infant formula

ad lib

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Minute

Maximum Eligible Age

24 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institute of Child Health

OTHER

Sponsor Role collaborator

Abbott Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Barbara Marriage, PhD

Role: STUDY_CHAIR

Abbott Nutrition

Locations

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MRC Childhood Nutrition Research Center, Institute of Child Health

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Gonzalez-Garay AG, Serralde-Zuniga AE, Medina Vera I, Velasco Hidalgo L, Alonso Ocana MV. Higher versus lower protein intake in formula-fed term infants. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD013758. doi: 10.1002/14651858.CD013758.pub2.

Reference Type DERIVED
PMID: 37929831 (View on PubMed)

Other Identifiers

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AK65

Identifier Type: -

Identifier Source: org_study_id

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