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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01721512

Enrollment

160

Registered

2012-11-05

Start date

2010-09-30

Completion date

2011-11-30

Last updated

2012-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth

Keywords

Prospective observational study, Breast feeding, Infant formula, Infant, Indonesia

Brief summary

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

Interventions

OTHERBreastfeeding

OTHERInfant formula

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Weeks to 6 Weeks

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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
Developmental progress	12 months	Developmental progress: assessed by Ages and Stages
Gut integrity	3 months	Gut integrity: faecal Alpha1-antitrypsin and faecal calprotectin

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026