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

Completed

• Conditions: Growth
• Interventions: Other: Breastfeeding; Other: Infant formula

• Registration Number: NCT01721512
• Lead Sponsor: Indonesia University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2012-11
• Study First Submitted: 2012-11-01
• Study First Submitted QC: 2012-11-02
• Last Update Submitted: 2012-11-02
• Study First Posted: 2012-11-04
• Last Update Posted: 2012-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast-fed infants	Breastfeeding	80 infants of mothers who plan to exclusively breastfeed for at least 6 months.
Formula-fed infants	Infant formula	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

Primary Outcome Measures

Name	Time	Method
Infant weight, body length head circumference	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 Outcome Measures

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

Trial Locations

Locations (1)

Universitas Indonesia; 🇮🇩 Jakarta, Indonesia