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Completed

NCT Number: NCT05959460

Assessing Exclusive Breastfeeding Practice

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.

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Key information

Age range

3 month–40 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deuterium dose-to-mother method for assessing breastfeeding

Other

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

Primary outcomes

  1. Non-milk oral intake

    Time frame: Jan 2016 - Dec 2020

    Quantity of non-milk oral intake (g)

  2. Human milk intake

    Time frame: Jan 2016 - Dec 2020

    Quantity of milk intake (g)

Secondary outcomes

  1. Body composition of mothers: total body water

    Time frame: Jan 2016 - Dec 2020

    Total body water in kilograms and as a percentage of body weight

  2. Body composition of mothers: fat free mass

    Time frame: Jan 2016 - Dec 2020

    Fat free mass in kilograms and as a percentage of body weight

  3. Body composition of mothers: fat mass

    Time frame: Jan 2016 - Dec 2020

    Fat mass in kilograms and as a percentage of body weight

  4. Weight of infants

    Time frame: Jan 2016 - Dec 2020

    Body weight in kilograms

  5. length of infants

    Time frame: 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.

  6. Weight of mothers

    Time frame: Jan 2016 - Dec 2020

    Body weight in kilograms

  7. Height of mothers

    Time frame: Jan 2016 - Dec 2020

    Height in centimeters. The body mass index (BMI) was calculated by dividing weight in kilograms by height in meters squared.

  8. Body mass index of mothers

    Time frame: Jan 2016 - Dec 2020

    weight in kilograms divided by height in meters squared

  9. Breastfeeding pattern

    Time frame: Jan 2016 - Dec 2020

    Breastfeeding pattern based on questionnaire

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
Jul 25, 2023
Registry last updated
Apr 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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