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

Completed

• Conditions: Breast Feeding
• Interventions: Other: no intervention

• 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.

Basic Information
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Recruitment & Eligibility
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Study & Design

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Predominant breastfeeding (PBF)	no intervention	providing breast milk plus other liquids (water and water-based drinks, fruit juice) and ORS, drops and syrups (vitamins, minerals, medicines)
Exclusive breastfeeding (EBF)	no intervention	provision of breast milk only, allowing only receiving oral rehydration salts (ORS), drops and syrups (vitamins, minerals, medicines) as necessary
Partial breastfeeding (PartBF)	no intervention	provision of breast milk plus infant formula or cow milk or other solid/semi-solid complementary foods

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