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

This study has been completed.
Sponsor:
Collaborator:
Fonterra Brands (Singapore) PTE LTD
Information provided by (Responsible Party):
Prof. Agus Firmansyah, MD, Ph.D, Indonesia University
ClinicalTrials.gov Identifier:
NCT01721512
First received: November 1, 2012
Last updated: November 2, 2012
Last verified: November 2012
History of Changes
  Purpose

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


Condition Intervention
Growth
 Other: Breastfeeding
Other: Infant formula

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Growth and Development of Breast and Formula Fed (Containing Synbiotics and LCPUFA) Term Asian Infants.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Indonesia University:

Primary Outcome Measures:
  • Infant weight, body length head circumference [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Gastrointestinal tolerance [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Gastrointestinal tolerance: stool frequency and consistency using Bristol Stool Chart monthly up to 6 months

  • Indicators or formula tolerance [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Indicators or formula tolerance: crying, irritability, sleep patterns

  • General health [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    General health: any hospitalisation, doctor visits, symptoms of respiratory or gastrointestinal infection, fever, antibiotic and medication usage

  • Gut integrity [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Gut integrity: faecal Alpha1-antitrypsin and faecal calprotectin

  • Gut microflora [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Gut microflora: real time PCR

  • Developmental progress [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Developmental progress: assessed by Ages and Stages


Biospecimen Retention:   Samples With DNA

Faecal samples


Enrollment: 160
Study Start Date: September 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 6 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01721512

Locations
Indonesia
Universitas Indonesia
Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
Fonterra Brands (Singapore) PTE LTD
Investigators
Principal Investigator: Agus Firmansyah, Professor, MD, PhD, SpA(K) University of Indonesia
  More Information

No publications provided

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
ClinicalTrials.gov Identifier: NCT01721512     History of Changes
Other Study ID Numbers: Project Grow
Study First Received: November 1, 2012
Last Updated: November 2, 2012
Health Authority: Fonterra Maternal and Pediatric Advisory Board, New Zealand':'

Keywords provided by Indonesia University:
Prospective observational study
Breast feeding
Infant formula
Infant
Indonesia

ClinicalTrials.gov processed this record on May 16, 2013