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Assessing Exclusive Breastfeeding Practice

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05959460
Enrollment
206
Registered
2023-07-25
Start date
2016-01-01
Completion date
2020-01-01
Last updated
2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Milk, Exclusive Breastfeeding, Human Milk

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.

Interventions

OTHERDeuterium dose-to-mother method for assessing breastfeeding

Exclusive breastfeeding practice was compared between maternal recall and the deuterium dose-to-mother method.

Sponsors

Pakistan Institute of Nuclear Science and Technology (PINSTECH)
CollaboratorOTHER_GOV
Faculty of Medicine, University of Ruhuna, Sri Lanka
CollaboratorUNKNOWN
National Institute of Nutrition, Vietnam
CollaboratorOTHER_GOV
International Centre for Diarrhoeal Disease Research, Bangladesh
CollaboratorOTHER
International Atomic Energy Agency
CollaboratorOTHER_GOV
St. John's Research Institute
CollaboratorOTHER
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
CollaboratorOTHER
Research Organization for Nuclear Energy-BRIN Indonesia
CollaboratorUNKNOWN
National University of Malaysia
CollaboratorOTHER
National Center for Maternal and Child Health, Mongolia
CollaboratorUNKNOWN
Mahidol University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Months to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Non-milk oral intakeJan 2016 - Dec 2020Quantity of non-milk oral intake (g)
Human milk intakeJan 2016 - Dec 2020Quantity of milk intake (g)

Secondary

MeasureTime frameDescription
Body composition of mothers: fat massJan 2016 - Dec 2020Fat mass in kilograms and as a percentage of body weight
Weight of infantsJan 2016 - Dec 2020Body weight in kilograms
length of infantsJan 2016 - Dec 2020Body length in centimeters. Weight-for-age, length-for-age, and weight-for-length z-scores were calculated based on the World Health Organization (WHO) growth standard.
Body composition of mothers: total body waterJan 2016 - Dec 2020Total body water in kilograms and as a percentage of body weight
Height of mothersJan 2016 - Dec 2020Height in centimeters. The body mass index (BMI) was calculated by dividing weight in kilograms by height in meters squared.
Body mass index of mothersJan 2016 - Dec 2020weight in kilograms divided by height in meters squared
Breastfeeding patternJan 2016 - Dec 2020Breastfeeding pattern based on questionnaire
Weight of mothersJan 2016 - Dec 2020Body weight in kilograms
Body composition of mothers: fat free massJan 2016 - Dec 2020Fat free mass in kilograms and as a percentage of body weight

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026