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

NCT01721512 | Completed DMC

• 1 other identifier: Project Grow
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Growth

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Gastrointestinal tolerance

  6 months

• Indicators or formula tolerance

  12 months

• General health

  12 months

• Gut integrity

  3 months

• Gut microflora

  3 months

Study Arms (2)

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

Interventions

Breastfeeding OTHER

Breast-fed infants

Infant formula OTHER

Formula-fed infants

Eligibility Criteria

• Age: 2 Weeks - 6 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Healthy infants recruited from Jati Padang, Pasar Minggu District, South Jakarta, Indonesia

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Indonesia University: lead
• Fonterra Brands (Singapore) PTE LTD: collaborator

Study Sites (1)

Universitas Indonesia

Jakarta, Jakarta Special Capital Region, 10430, Indonesia

Location

Related Publications (1)

• Dwipoerwantoro PG, Mansyur M, Oswari H, Makrides M, Cleghorn G, Firmansyah A. Growth of Indonesian Infants Compared With World Health Organization Growth Standards. J Pediatr Gastroenterol Nutr. 2015 Aug;61(2):248-52. doi: 10.1097/MPG.0000000000000770.

  PMID: 25710823 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Faecal samples

MeSH Terms

Conditions

Breast Feeding

Interventions

Lactation; Infant Formula

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Postpartum Period; Milk Substitutes; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food, Formulated; Foods, Specialized; Food; Infant Food; Food and Beverages

Study Officials

• Agus Firmansyah, Professor, MD, PhD, SpA(K)

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief, Division of Gastrohepatology, Department of Child Health, Medical Faculty, University of Indonesia

Study Record Dates

• First Submitted: November 1, 2012
• First Posted: November 5, 2012
• Study Start: September 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: November 5, 2012

Record last verified: 2012-11

Locations

ID (1)