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Clinical Trials/NCT01721512
NCT01721512
Completed
Not Applicable

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

Indonesia University1 site in 1 country160 target enrollmentSeptember 2010
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ConditionsGrowth

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Growth
Sponsor
Indonesia University
Enrollment
160
Locations
1
Primary Endpoint
Infant weight, body length head circumference
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
November 2011
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Prof. Agus Firmansyah, MD, Ph.D

Professor and Chief, Division of Gastrohepatology, Department of Child Health, Medical Faculty, University of Indonesia

Indonesia University

Eligibility Criteria

Inclusion Criteria

  • •Breast-fed:
  • •Mother intends to exclusively breast-feed from birth to at least 4 months;
  • •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:
  • •Mother is exclusively feeding infant formula milk less than or equal to 6 weeks of birth and has no prospect of breastfeeding;
  • •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;
  • •Mother consents to her infant receiving trial infant formula for 12 months.

Exclusion Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Gastrointestinal tolerance(6 months)
  • Gut integrity(3 months)
  • Developmental progress(12 months)
  • Gut microflora(3 months)
  • Indicators or formula tolerance(12 months)
  • General health(12 months)

Study Sites (1)

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