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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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) Indonesia University
  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 October 23, 2014