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Assessing Exclusive Breastfeeding Practice

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ClinicalTrials.gov Identifier: NCT05959460
Recruitment Status : Completed
First Posted : July 25, 2023
Last Update Posted : April 2, 2024
Sponsor:
Collaborators:
Pakistan Institute of Nuclear Science and Technology (PINSTECH)
Faculty of Medicine, University of Ruhuna, Sri Lanka
National Institute of Nutrition, Vietnam
International Centre for Diarrhoeal Disease Research, Bangladesh
International Atomic Energy Agency
St. John's Research Institute
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
Research Organization for Nuclear Energy-BRIN Indonesia
National University of Malaysia
National Center for Maternal and Child Health, Mongolia
Information provided by (Responsible Party):
Pattanee Winichagoon, Mahidol University

Study Description
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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.

Condition or disease Intervention/treatment
Exclusive Breastfeeding Human Milk Breast Milk Other: Deuterium dose-to-mother method for assessing breastfeeding

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.

Study Design
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Study Type : Observational
Actual Enrollment : 206 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of Maternal Recall of Exclusive Breastfeeding by the Deuterium Dilution Method: a Study in 7 Asian Countries
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Groups and Cohorts
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Group/Cohort Intervention/treatment
1
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.
 Other: Deuterium dose-to-mother method for assessing breastfeeding
Exclusive breastfeeding practice was compared between maternal recall and the deuterium dose-to-mother method.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05959460


Sponsors and Collaborators
Mahidol University
Pakistan Institute of Nuclear Science and Technology (PINSTECH)
Faculty of Medicine, University of Ruhuna, Sri Lanka
National Institute of Nutrition, Vietnam
International Centre for Diarrhoeal Disease Research, Bangladesh
International Atomic Energy Agency
St. John's Research Institute
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
Research Organization for Nuclear Energy-BRIN Indonesia
National University of Malaysia
National Center for Maternal and Child Health, Mongolia
Investigators
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Study Director: Tippawan Pongcharoen, PhD Mahidol U
More Information
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Additional Information:

Publications:

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Responsible Party: Pattanee Winichagoon, Associate Professor Dr., Mahidol University
ClinicalTrials.gov Identifier: NCT05959460    
Other Study ID Numbers: RAS6073
First Posted: July 25, 2023    Key Record Dates
Last Update Posted: April 2, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No