Clinical trial NCT05959460: Assessing Exclusive Breastfeeding Practice
Official title: Validation of Maternal Recall of Exclusive Breastfeeding by the Deuterium Dilution Method: a Study in 7 Asian Countries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exclusive Breastfeeding
Human Milk
Breast Milk
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Pakistan Institute of Nuclear Science and Technology (PINSTECH)
name: Faculty of Medicine, University of Ruhuna, Sri Lanka
name: National Institute of Nutrition, Vietnam
name: International Centre for Diarrhoeal Disease Research, Bangladesh
name: International Atomic Energy Agency
name: St. John's Research Institute
name: National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
name: Research Organization for Nuclear Energy-BRIN Indonesia
name: National University of Malaysia
name: National Center for Maternal and Child Health, Mongolia
First posted: 2023-07-25
Enrollment: 206
Sex: ALL
Minimum age (years): 3
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants were mother-baby pairs who were eligible according to the inclusion and exclusion criteria. There were recruited from hospitals, health clinics, or communities.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Mother who practice exclusive breastfeeding
* Age of mother 18 - 40 years
* Parity: no more than 3
* Baby 3 month ± 7 days
* Nutritional status Weight-for-height Z score (WHZ) \> -2
* Full term baby (37 - 40 weeks)

Exclusion Criteria:

* Twin or more baby
* Low birth weight
* Baby with oedema
* Mother with fluid retention disease (kidney disease, heart disease, hypothyroidism)
* Smoking mother
* Drinking alcohol mother

Primary outcomes:
measure: Non-milk oral intake
timeFrame: Jan 2016 - Dec 2020
measure: Human milk intake
timeFrame: Jan 2016 - Dec 2020
Secondary outcomes:
measure: Body composition of mothers: total body water
timeFrame: Jan 2016 - Dec 2020
measure: Body composition of mothers: fat free mass
timeFrame: Jan 2016 - Dec 2020
measure: Body composition of mothers: fat mass
timeFrame: Jan 2016 - Dec 2020
measure: Weight of infants
timeFrame: Jan 2016 - Dec 2020
measure: length of infants
timeFrame: Jan 2016 - Dec 2020
measure: Weight of mothers
timeFrame: Jan 2016 - Dec 2020
measure: Height of mothers
timeFrame: Jan 2016 - Dec 2020
measure: Body mass index of mothers
timeFrame: Jan 2016 - Dec 2020
measure: Breastfeeding pattern
timeFrame: Jan 2016 - Dec 2020
Other outcomes:
Locations:
Study officials:
affiliation: Mahidol U
name: Tippawan Pongcharoen, PhD
role: STUDY_DIRECTOR
References:
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.
citation: Mulol H, Coutsoudis A. Limitations of maternal recall for measuring exclusive breastfeeding rates in South African mothers. Int Breastfeed J. 2018 May 25;13:19. doi: 10.1186/s13006-018-0159-8. eCollection 2018.