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

University of Indonesia (UI)

Status: Completed

Conditions: Growth

Treatments: Other: Infant formula; Other: Breastfeeding

Study type: Observational

Funder types: Other

Identifiers

NCT01721512

Project Grow

Details and patient eligibility

About

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

Enrollment: 160 patients

Sex: All

Ages: 2 to 6 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

160 participants in 2 patient groups

Breast-fed infants

Description:

80 infants of mothers who plan to exclusively breastfeed for at least 6 months.

Treatment:

Other: Breastfeeding

Formula-fed infants

Description:

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

Treatment:

Other: Infant formula