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

Breast Feeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04020640
• Other study ID #: MU-IRB 2012/114.0712
• Status: Completed
• Start date: July 4, 2013
• Est. completion date: November 22, 2016

Study information

• Verified date: July 2019
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: November 22, 2016
• Est. primary completion date: November 22, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Breast Feeding

Intervention

Other:
• no intervention
Measure human intake using stable isotope technique

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	International Atomic Energy Agency

References & Publications (1)

Vogelezang S, Santos S, van der Beek EM, Abrahamse-Berkeveld M, Duijts L, van der Lugt A, Felix JF, Jaddoe VWV. Infant breastfeeding and childhood general, visceral, liver, and pericardial fat measures assessed by magnetic resonance imaging. Am J Clin Nutr. 2018 Oct 1;108(4):722-729. doi: 10.1093/ajcn/nqy137. — View Citation

Outcome

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