The Growth and Development of Breast and Formula Fed Term Asian Infants

November 2, 2012 updated by: Prof. Agus Firmansyah, MD, Ph.D, Indonesia University

The Growth and Development of Breast and Formula Fed (Containing Synbiotics and LCPUFA) Term Asian Infants.

Prospective cohort study of breast and formula fed infants in a suburban setting in Jakarta, Indonesia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
      • Jakarta, Indonesia, 10430
        • Universitas Indonesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 weeks to 1 month (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy infants recruited from Jati Padang, Pasar Minggu District, South Jakarta, Indonesia

Description

Inclusion Criteria:

  • Breast-fed: 1. Mother intends to exclusively breast-feed from birth to at least 4 months; 2. A healthy term infant with gestational age fo 37-42 weeks and birth weight greater than or equal to 2.5 kg and equal or less than 4.75 kg.
  • Formula-fed: 1. Mother is exclusively feeding infant formula milk less than or equal to 6 weeks of birth and has no prospect of breastfeeding; 2. A healthy term infant with gestational age fo 37-42 weeks and birth weight greater than or equal to 2.5 kg and equal or less than 4.75 kg; 3. Mother consents to her infant receiving trial infant formula for 12 months.

Exclusion Criteria:

  • 1. Severe congenital or metabolic disease likely to affect infant feeding or infant growth.
  • 2. Multiple birth

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Breast-fed infants
80 infants of mothers who plan to exclusively breastfeed for at least 6 months.
Other: Breastfeeding
Formula-fed infants
  1. Mother is exclusively feeding infant formula milk less than or equal to 6 weeks of birth and has no prospect of breastfeeding.
  2. Mother consents to her infant receiving trial infant formula for 12 months
Other: Infant formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant weight, body length head circumference
Time Frame: 12 months
Infant weight, body length head circumference at enrolment, 2 weeks, 4 weeks and monthly thereafter until 6 months, and then at 8, 10 and 12 months.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastrointestinal tolerance
Time Frame: 6 months
Gastrointestinal tolerance: stool frequency and consistency using Bristol Stool Chart monthly up to 6 months
6 months
Indicators or formula tolerance
Time Frame: 12 months
Indicators or formula tolerance: crying, irritability, sleep patterns
12 months
General health
Time Frame: 12 months
General health: any hospitalisation, doctor visits, symptoms of respiratory or gastrointestinal infection, fever, antibiotic and medication usage
12 months
Gut integrity
Time Frame: 3 months
Gut integrity: faecal Alpha1-antitrypsin and faecal calprotectin
3 months
Gut microflora
Time Frame: 3 months
Gut microflora: real time PCR
3 months
Developmental progress
Time Frame: 12 months
Developmental progress: assessed by Ages and Stages
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Collaborators

Fonterra Brands (Singapore) PTE LTD

Investigators

  • Principal Investigator: Agus Firmansyah, Professor, MD, PhD, SpA(K), Indonesia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

November 1, 2012

First Submitted That Met QC Criteria

November 2, 2012

First Posted (Estimate)

November 4, 2012

Study Record Updates

Last Update Posted (Estimate)

November 4, 2012

Last Update Submitted That Met QC Criteria

November 2, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Project Grow

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Growth

Clinical Trials on Infant formula

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe