Exclusive BreastfeedingNCT05959460
Assessing Exclusive Breastfeeding Practice
An observational study of Exclusive Breastfeeding and Human Milk, run by Mahidol University.
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. Read more about this study
- Who is it for?
- Ages 3 months to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Exclusive Breastfeeding, Human Milk, Breast Milk
- What is being tested?
- Deuterium dose-to-mother method for assessing breastfeeding
- How many people
- 206 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
About this study
Official title: Validation of Maternal Recall of Exclusive Breastfeeding by the Deuterium Dilution Method: a Study in 7 Asian Countries
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.
Read the 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.
- Conditions
- Exclusive Breastfeeding, Human Milk, Breast Milk
- Being tested
- Deuterium dose-to-mother method for assessing breastfeeding
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deuterium dose-to-mother method for assessing breastfeedingOther
Exclusive breastfeeding practice was compared between maternal recall and the deuterium dose-to-mother method.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Deuterium dose-to-mother method for assessing breastfeeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-milk oral intake
Quantity of non-milk oral intake (g)
Measured: Jan 2016 - Dec 2020
Human milk intake
Quantity of milk intake (g)
Measured: Jan 2016 - Dec 2020
Secondary outcomes (9)
Body composition of mothers: total body water
Total body water in kilograms and as a percentage of body weight
Measured: Jan 2016 - Dec 2020
Body composition of mothers: fat free mass
Fat free mass in kilograms and as a percentage of body weight
Measured: Jan 2016 - Dec 2020
Body composition of mothers: fat mass
Fat mass in kilograms and as a percentage of body weight
Measured: Jan 2016 - Dec 2020
Weight of infants
Body weight in kilograms
Measured: Jan 2016 - Dec 2020
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.
Measured: Jan 2016 - Dec 2020
Weight of mothers
Body weight in kilograms
Measured: Jan 2016 - Dec 2020
Height of mothers
Height in centimeters. The body mass index (BMI) was calculated by dividing weight in kilograms by height in meters squared.
Measured: Jan 2016 - Dec 2020
Body mass index of mothers
weight in kilograms divided by height in meters squared
Measured: Jan 2016 - Dec 2020
Breastfeeding pattern
Breastfeeding pattern based on questionnaire
Measured: Jan 2016 - Dec 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start1 Jan 2016
- Primary completion31 Dec 2018
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Exclusive BreastfeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Pattanee Winichagoon, Mahidol University
- Investigators
- Tippawan Pongcharoen, PhD, Study director, Mahidol U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959460
- Sponsor's protocol ID
- RAS6073
- Status last verified
- Mar 2024
- First submitted
- 16 Jul 2023
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32799695Mulol 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.
PubMed 29849742
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Maternal Recall of Exclusive Breastfeeding by the Deuterium Dilution Method: a Study in 7 Asian Countries
- ClinicalTrials.gov ID
- NCT05959460
- Acronym / sponsor ID
- RAS6073
- Conditions
- Exclusive Breastfeeding, Human Milk, Breast Milk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- 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
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 25 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Deuterium dose-to-mother method for assessing breastfeedingThis 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. |
Who may qualify
- Ages
- 3 months to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Twin or more baby
- Low birth weight
- Baby with oedema
- Mother with fluid retention disease (kidney disease, heart disease, hypothyroidism)
- Smoking mother
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deuterium dose-to-mother method for assessing breastfeedingExclusive breastfeeding practice was compared between maternal recall and the deuterium dose-to-mother method. | Other | 1 |
Primary outcome
Non-milk oral intake
Time frame: Jan 2016 - Dec 2020
Quantity of non-milk oral intake (g)
Human milk intake
Time frame: Jan 2016 - Dec 2020
Quantity of milk intake (g)
9 secondary outcomes
Body composition of mothers: total body water
Time frame: Jan 2016 - Dec 2020
Body composition of mothers: fat free mass
Time frame: Jan 2016 - Dec 2020
Body composition of mothers: fat mass
Time frame: Jan 2016 - Dec 2020
Weight of infants
Time frame: Jan 2016 - Dec 2020
length of infants
Time frame: Jan 2016 - Dec 2020
Weight of mothers
Time frame: Jan 2016 - Dec 2020
Height of mothers
Time frame: Jan 2016 - Dec 2020
Body mass index of mothers
Time frame: Jan 2016 - Dec 2020
Breastfeeding pattern
Time frame: Jan 2016 - Dec 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Background: PubMed 32799695Tongchom 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.
- Background: PubMed 29849742Mulol 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tippawan Pongcharoen, PhD study director
Mahidol U
Questions about this trial
What is this clinical trial studying?
An observational study of Exclusive Breastfeeding and Human Milk, run by Mahidol University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-milk oral intake (time frame: Jan 2016 - Dec 2020). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05959460, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.