Assessing Exclusive Breastfeeding Practice
- Conditions
- Exclusive BreastfeedingHuman MilkBreast Milk
- Interventions
- Other: Deuterium dose-to-mother method for assessing breastfeeding
- Registration Number
- NCT05959460
- Lead Sponsor
- Mahidol University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 206
- 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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 Deuterium dose-to-mother method for assessing breastfeeding This is an observation study to determine exclusive breastfeeding practice. Mother-child pairs were enrolled at 3 months ± 7d and were followed-up at 6 months ± 7d. Questionnaire was administered. Then, baseline saliva samples were collected and deuterium oxide dose was administered. Then, post-dose saliva samples were collected.
- Primary Outcome Measures
Name Time Method Non-milk oral intake Jan 2016 - Dec 2020 Quantity of non-milk oral intake (g)
Human milk intake Jan 2016 - Dec 2020 Quantity of milk intake (g)
- Secondary Outcome Measures
Name Time Method Weight of mothers Jan 2016 - Dec 2020 Body weight in kilograms
Height of mothers Jan 2016 - Dec 2020 Height in centimeters. The body mass index (BMI) was calculated by dividing weight in kilograms by height in meters squared.
length of infants Jan 2016 - Dec 2020 Body 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.
Breastfeeding pattern Jan 2016 - Dec 2020 Breastfeeding pattern based on questionnaire
Body composition of mothers: total body water Jan 2016 - Dec 2020 Total body water in kilograms and as a percentage of body weight
Body composition of mothers: fat free mass Jan 2016 - Dec 2020 Fat free mass in kilograms and as a percentage of body weight
Body composition of mothers: fat mass Jan 2016 - Dec 2020 Fat mass in kilograms and as a percentage of body weight
Weight of infants Jan 2016 - Dec 2020 Body weight in kilograms
Body mass index of mothers Jan 2016 - Dec 2020 weight in kilograms divided by height in meters squared