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CompletedNCT01721512Updated Nov 4, 2012

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

An observational study in Growth, sponsored by Indonesia University. Completed at 1 site in Indonesia. Open to participants aged 2 Weeks to 6 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-11-04.

Sponsored by Indonesia University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
160
Ages
2 Weeks to 6 Weeks
Sex
All
01

Study summary

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

02

Conditions studied

  • Growth

Keywords

  • Prospective observational study
  • Breast feeding
  • Infant formula
  • Infant
  • Indonesia
03

In context

Lead sponsor

Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Weeks to 6 Weeks
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

    1. Severe congenital or metabolic disease likely to affect infant feeding or infant growth.
    1. Multiple birth
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
160 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

Interventions

  • OtherBreastfeeding
  • OtherInfant formula
06

What researchers measure

Primary outcomes

  1. Infant weight, body length head circumference

    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.

    Time frame: 12 months

Secondary outcomes

  1. Gastrointestinal tolerance

    Gastrointestinal tolerance: stool frequency and consistency using Bristol Stool Chart monthly up to 6 months

    Time frame: 6 months

  2. Indicators or formula tolerance

    Indicators or formula tolerance: crying, irritability, sleep patterns

    Time frame: 12 months

  3. General health

    General health: any hospitalisation, doctor visits, symptoms of respiratory or gastrointestinal infection, fever, antibiotic and medication usage

    Time frame: 12 months

  4. Gut integrity

    Gut integrity: faecal Alpha1-antitrypsin and faecal calprotectin

    Time frame: 3 months

  5. Gut microflora

    Gut microflora: real time PCR

    Time frame: 3 months

  6. Developmental progress

    Developmental progress: assessed by Ages and Stages

    Time frame: 12 months

07

Study locations

1 site
  • Universitas Indonesia
    Jakarta, 10430, Indonesia
08

References and documents

Publications

  • Dwipoerwantoro PG, Mansyur M, Oswari H, Makrides M, Cleghorn G, Firmansyah A. Growth of Indonesian Infants Compared With World Health Organization Growth Standards. J Pediatr Gastroenterol Nutr. 2015 Aug;61(2):248-52. doi: 10.1097/MPG.0000000000000770. PubMed 25710823 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01721512
Lead sponsor
Indonesia University
Collaborators
Fonterra Brands (Singapore) PTE LTD
Responsible party
Prof. Agus Firmansyah, MD, Ph.D (Professor and Chief, Division of Gastrohepatology, Department of Child Health, Medical Faculty, University of Indonesia, Indonesia University) — Principal investigator
First posted
Nov 4, 2012
Start date
Sep 2010
Primary completion
Nov 2011
Completion
Nov 2011
Last update
Nov 4, 2012

Study contacts

Agus Firmansyah, Professor, MD, PhD, SpA(K)
principal investigator · Indonesia University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

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