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

July 12, 2019 updated by: Wanabhorn Tongchom, Mahidol University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 weeks to 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Exclusive breastfeeding (EBF)
provision of breast milk only, allowing only receiving oral rehydration salts (ORS), drops and syrups (vitamins, minerals, medicines) as necessary
Other: no intervention
Measure human intake using stable isotope technique
Other Names:
  • Observational study
Predominant breastfeeding (PBF)
providing breast milk plus other liquids (water and water-based drinks, fruit juice) and ORS, drops and syrups (vitamins, minerals, medicines)
Other: no intervention
Measure human intake using stable isotope technique
Other Names:
  • Observational study
Partial breastfeeding (PartBF)
provision of breast milk plus infant formula or cow milk or other solid/semi-solid complementary foods
Other: no intervention
Measure human intake using stable isotope technique
Other Names:
  • Observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Collaborators

International Atomic Energy Agency

Investigators

  • Principal Investigator: WANABHORN TONGCHOM, PhD, Institute of Nutrition

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2013

Primary Completion (Actual)

November 22, 2015

Study Completion (Actual)

November 22, 2016

Study Registration Dates

First Submitted

July 12, 2019

First Submitted That Met QC Criteria

July 12, 2019

First Posted (Actual)

July 16, 2019

Study Record Updates

Last Update Posted (Actual)

July 16, 2019

Last Update Submitted That Met QC Criteria

July 12, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MU-IRB 2012/114.0712

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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