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

Growth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01721512
• Other study ID #: Project Grow
• Status: Completed
• Phase: N/A
• First received: November 1, 2012
• Last updated: November 2, 2012
• Start date: September 2010
• Est. completion date: November 2011

Study information

• Verified date: November 2012
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Fonterra Maternal and Pediatric Advisory Board, New Zealand':'
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 6 Weeks

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Growth

Intervention

Other:
• Breastfeeding

• Infant formula

Locations

Country	Name	City	State
Indonesia	Universitas Indonesia	Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
Indonesia University	Fonterra Brands (Singapore) PTE LTD

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant weight, body length head circumference	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.	12 months	Yes
Secondary	Gastrointestinal tolerance	Gastrointestinal tolerance: stool frequency and consistency using Bristol Stool Chart monthly up to 6 months	6 months	Yes
Secondary	Indicators or formula tolerance	Indicators or formula tolerance: crying, irritability, sleep patterns	12 months	Yes
Secondary	General health	General health: any hospitalisation, doctor visits, symptoms of respiratory or gastrointestinal infection, fever, antibiotic and medication usage	12 months	Yes
Secondary	Gut integrity	Gut integrity: faecal Alpha1-antitrypsin and faecal calprotectin	3 months	Yes
Secondary	Gut microflora	Gut microflora: real time PCR	3 months	No
Secondary	Developmental progress	Developmental progress: assessed by Ages and Stages	12 months	No