Clinical trial NCT04020640: Infant Feeding Practices in Transition: Breast Milk Intake, Complementary Feeding and Body Composition During Infancy
Official title: Infant Feeding Practices in Transition: Breast Milk Intake, Complementary Feeding and Body Composition During Infancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Feeding
Keywords: human milk intake
dose-to-mother deuterium oxide
exclusive breastfeeding
predominant breastfeeding
partial breastfeeding
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: International Atomic Energy Agency
First posted: 2019-07-16
Enrollment: 110
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The mother-infant pairs were recruited at the Ratchaburi hospital and Health promoting hospital, Health promotion center region 5, both situated in Ratchaburi province, central Thailand.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Human milk intake of Thai breastfed infants during the first 6 months using the dose-to-mother deuterium dilution method
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Nutrition
name: WANABHORN TONGCHOM, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Tongchom W, Pongcharoen T, Judprasong K, Udomkesmalee E, Kriengsinyos W, Winichagoon P. Human Milk Intake of Thai Breastfed Infants During the First 6 Months Using the Dose-to-Mother Deuterium Dilution Method. Food Nutr Bull. 2020 Sep;41(3):343-354. doi: 10.1177/0379572120943092. Epub 2020 Aug 17.