Infant Feeding Practices in Transition: Breast Milk Intake, Complementary Feeding and Body Composition During Infancy

Completed

• Conditions: Breast Feeding

• Registration Number: NCT04020640
• Lead Sponsor: Mahidol University

Brief Summary

Research Aim: We assessed human milk intakes of Thai infants during the first 6 months comparing exclusive (EBF), predominant (PBF) and partial (PartBF) breastfeeding.

Methods: One-hundred and ten apparently healthy Thai lactating mother-infant pairs were followed from birth. Human milk intakes were determined at 6 weeks, 3 and 6 months, using the DTM method. Daily energy and protein intakes were assessed using 3-day non-consecutive 24-hour recalls. Socio-demographic characteristics were collected using a questionnaire. For comparisons among breastfeeding practices, one-way ANOVA with Tukey's post hoc test was used for normally distributed data, or Kruskal-Wallis Test with Mann-Whitney U Test for not normally distributed data.

Detailed Description

Human milk intakes were comparable between the EBF and PBF infants during the first 6 months, and provided the sole source of energy and protein; infant formula largely replaced breast milk among PartBF infants.

Study Timeline

• Study Start: 2013-07-04
• Primary Completion: 2015-11-22
• Study Completion: 2016-11-22
• Status Verified: 2019-07
• Study First Submitted: 2019-07-12
• Study First Submitted QC: 2019-07-12
• Last Update Submitted: 2019-07-12
• Study First Posted: 2019-07-16
• Last Update Posted: 2019-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Apparently healthy women aged 20-35 year
• Had pre-pregnancy BMI in the normal range (18.5-25 kg/m2)
• Planned to breastfeed their baby for at least 6 months
• Being full term infants (gestational age 37-42 weeks) and singleton
• Had normal birth weight (2,500 - 4,000 g)
• Signed written informed consent to participate in the study

Exclusion Criteria

• Infant: preterm; twin; low and high birth weight; congenital diseases
• Mother: chronic diseases needed to get medicine and treatment; underweight and obesity
• Mother and baby did not stay together throughout 12 months of infant age

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Human milk intake of Thai breastfed infants during the first 6 months using the dose-to-mother deuterium dilution method	6 months	assessed human milk intakes of Thai infants during the first 6 months comparing exclusive (EBF), predominant (PBF) and partial (PartBF) breastfeeding