Assessing Exclusive Breastfeeding Practice

Exclusive Breastfeeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05959460
• Other study ID #: RAS6073
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: January 1, 2020

Study information

• Verified date: March 2024
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: January 1, 2020
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Milk
• Exclusive Breastfeeding
• Human Milk

Intervention

Other:
• Deuterium dose-to-mother method for assessing breastfeeding
Exclusive breastfeeding practice was compared between maternal recall and the deuterium dose-to-mother method.

Locations

Country	Name	City	State
n/a

Sponsors (11)

Lead Sponsor

Collaborator

Mahidol University

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

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-milk oral intake	Quantity of non-milk oral intake (g)	Jan 2016 - Dec 2020
Primary	Human milk intake	Quantity of milk intake (g)	Jan 2016 - Dec 2020
Secondary	Body composition of mothers: total body water	Total body water in kilograms and as a percentage of body weight	Jan 2016 - Dec 2020
Secondary	Body composition of mothers: fat free mass	Fat free mass in kilograms and as a percentage of body weight	Jan 2016 - Dec 2020
Secondary	Body composition of mothers: fat mass	Fat mass in kilograms and as a percentage of body weight	Jan 2016 - Dec 2020
Secondary	Weight of infants	Body weight in kilograms	Jan 2016 - Dec 2020
Secondary	length of infants	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.	Jan 2016 - Dec 2020
Secondary	Weight of mothers	Body weight in kilograms	Jan 2016 - Dec 2020
Secondary	Height of mothers	Height in centimeters. The body mass index (BMI) was calculated by dividing weight in kilograms by height in meters squared.	Jan 2016 - Dec 2020
Secondary	Body mass index of mothers	weight in kilograms divided by height in meters squared	Jan 2016 - Dec 2020
Secondary	Breastfeeding pattern	Breastfeeding pattern based on questionnaire	Jan 2016 - Dec 2020

External Links

•   https://www.iaea.org/publications/8168/stable-isotope-technique-to-assess-intake-of-human-milk-in-breastfed-infants