NCT05959460

Assessing Exclusive Breastfeeding Practice

Validation of Maternal Recall of Exclusive Breastfeeding by the Deuterium Dilution Method: a Study in 7 Asian Countries

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 206 (actual)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 3 Months – 40 Years
• Healthy volunteers: Accepted

Summary

This study was a longitudinal design. The questionnaire on exclusive breastfeeding was administered and was validated against the deuterium oxide dose-to-mother technique to assess human milk intake of babies aged 3 and 6 mo.

Detailed description

This study is a longitudinal design that aimed to assess exclusive breastfeeding (EBF) practices in Asian countries and to compare the agreement in EBF between maternal recall and the dose-to-mother technique (DTM) technique. The questionnaire on exclusive breastfeeding was administered and was validated against the deuterium oxide dose-to-mother technique to assess human milk intake of babies aged 3 and 6 mo. The study planned to recruit 30 mother-baby pairs from each participated country. The was carried out in 7 countries in Asia, namely, Indonesia, Malaysia, Mongolia, Pakistan, Sri Lanka, Thailand, and Vietnam. Mothers were approached at child birth, to explain the project objective and obtain written informed consent. A screening questionnaire was administered to obtain the interest to participate in the study. Only mothers who intend to exclusive breastfeeding till 6 mo will be eligible for further information and sample collection. Isotope dosing of mothers and saliva sample collection were done when the baby is at 3 mo ± 1wk, when a questionnaire (validation questionnaire) was administered. A basal saliva sample was collected prior to dosing with deuterium oxide. The isotope dosing of the mother was given and saliva samples were collected (post-dose) on day 1,2,3,4 and days 13,14. The mother-baby pairs were followed up for another sample collection at 6 mo ± 1 wk and all procedures were repeated, including a questionnaire administration, basal sample collection, deuterium oxide dose administration, and post-dose sample collection. Body weight and height/length of mothers and infants were measured. All saliva samples were analyzed by Isotope ratio mass spectrometer (IRMS) or Fourier Transform Infrared Spectroscopy (FTIR). Quantity of breast milk intake, non milk oral intake (NMOI) and maternal body composition were determined using standard assumption and formulae developed by the International Atomic Energy Agency (IAEA). Children with NMOI ≥ 86.6 g/day were considered as non-EBF using stable isotopic DTM technique. The overall agreement of EBF classification between the recall and DTM techniques is presented using Kappa statistic with 95% confidence interval.

Conditions

• Exclusive Breastfeeding
• Human Milk
• Breast Milk

Interventions

Type	Name	Description
OTHER	Deuterium dose-to-mother method for assessing breastfeeding	Exclusive breastfeeding practice was compared between maternal recall and the deuterium dose-to-mother method.

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-12-31
• Completion: 2020-01-01
• First posted: 2023-07-25
• Last updated: 2024-04-02