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OpenTrials
Completed

NCT Number: NCT04020640

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

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.

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Key information

Conditions

Breast Feeding Behavior Feeding Behavior

Age range

2 week–6 month

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

Measure human intake using stable isotope technique

Other names: Observational study

Primary outcomes

  1. Human milk intake of Thai breastfed infants during the first 6 months using the dose-to-mother deuterium dilution method

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • International Atomic Energy Agency

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Jul 16, 2019
Registry last updated
Jul 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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