Breast FeedingNCT04020640
Infant Feeding Practices in Transition: Breast Milk Intake, Complementary Feeding and Body Composition During Infancy
An observational study of Breast Feeding, run by Mahidol University.
Trial summary
Research Aim: We assessed human milk intakes of Thai infants during the first 6 months comparing exclusive (EBF), predominant (PBF) and partial (PartBF) breastfeeding. Methods: One-hundred and ten apparently healthy Thai lactating mother-infant pairs were followed from birth. Read more about this study
- Who is it for?
- Ages 2 weeks to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding
- Type of treatment
- Pill or oral medicine
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 4 Jul 2013to 22 Nov 2016
- 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 2 weeks to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: The mother-infant pairs were recruited at the Ratchaburi hospital and Health promoting hospital, Health promotion center region 5, both situated in Ratchaburi province, central Thailand.
Who may be able to join
- Apparently healthy women aged 20-35 year
- Had pre-pregnancy BMI in the normal range (18.5-25 kg/m2)
- Planned to breastfeed their baby for at least 6 months
- Being full term infants (gestational age 37-42 weeks) and singleton
- Had normal birth weight (2,500 - 4,000 g)
- Signed written informed consent to participate in the study
Who cannot join
- Infant: preterm; twin; low and high birth weight; congenital diseases
- Mother: chronic diseases needed to get medicine and treatment; underweight and obesity
- Mother and baby did not stay together throughout 12 months of infant age
About this study
Research Aim: We assessed human milk intakes of Thai infants during the first 6 months comparing exclusive (EBF), predominant (PBF) and partial (PartBF) breastfeeding.
Methods: One-hundred and ten apparently healthy Thai lactating mother-infant pairs were followed from birth. Human milk intakes were determined at 6 weeks, 3 and 6 months, using the DTM method. Daily energy and protein intakes were assessed using 3-day non-consecutive 24-hour recalls. Socio-demographic characteristics were collected using a questionnaire. For comparisons among breastfeeding practices, one-way ANOVA with Tukey's post hoc test was used for normally distributed data, or Kruskal-Wallis Test with Mann-Whitney U Test for not normally distributed data.
Read the detailed description
Human milk intakes were comparable between the EBF and PBF infants during the first 6 months, and provided the sole source of energy and protein; infant formula largely replaced breast milk among PartBF infants.
- Conditions
- Breast Feeding
- Being tested
- no intervention
- Keywords
- human milk intake, dose-to-mother deuterium oxide, exclusive breastfeeding, predominant breastfeeding, partial 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.
no interventionOther
Also called Observational study
Measure human intake using stable isotope technique
| Study group | Role | What they receive |
|---|---|---|
| Exclusive breastfeeding (EBF) | provision of breast milk only, allowing only receiving oral rehydration salts (ORS), drops and syrups (vitamins, minerals, medicines) as necessary Receives: Other: no intervention | |
| Predominant breastfeeding (PBF) | providing breast milk plus other liquids (water and water-based drinks, fruit juice) and ORS, drops and syrups (vitamins, minerals, medicines) Receives: Other: no intervention | |
| Partial breastfeeding (PartBF) | provision of breast milk plus infant formula or cow milk or other solid/semi-solid complementary foods Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Human milk intake of Thai breastfed infants during the first 6 months using the dose-to-mother deuterium dilution method
assessed human milk intakes of Thai infants during the first 6 months comparing exclusive (EBF), predominant (PBF) and partial (PartBF) breastfeeding
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start4 Jul 2013
- Primary completion22 Nov 2015
- Study completion22 Nov 2016
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 Breast FeedingStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- International Atomic Energy Agency
- Responsible party
- Principal investigator, Wanabhorn Tongchom, Mahidol University
- Investigators
- WANABHORN TONGCHOM, PhD, Principal investigator, Institute of Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020640
- Sponsor's protocol ID
- MU-IRB 2012/114.0712
- Status last verified
- Jul 2019
- First submitted
- 12 Jul 2019
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vogelezang S, Santos S, van der Beek EM, Abrahamse-Berkeveld M, Duijts L, van der Lugt A, Felix JF, Jaddoe VWV. Infant breastfeeding and childhood general, visceral, liver, and pericardial fat measures assessed by magnetic resonance imaging. Am J Clin Nutr. 2018 Oct 1;108(4):722-729. doi: 10.1093/ajcn/nqy137.
PubMed 30107466Tongchom 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 32799695
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infant Feeding Practices in Transition: Breast Milk Intake, Complementary Feeding and Body Composition During Infancy
- ClinicalTrials.gov ID
- NCT04020640
- Acronym / sponsor ID
- MU-IRB 2012/114.0712
- Conditions
- Breast Feeding
- Keywords
- human milk intake, dose-to-mother deuterium oxide, exclusive breastfeeding, predominant breastfeeding, partial breastfeeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- International Atomic Energy Agency
- Study start
- 4 Jul 2013 (actual)
- Primary completion
- 22 Nov 2015 (actual)
- Study completion
- 22 Nov 2016 (actual)
- First posted
- 16 Jul 2019 (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.
Research Aim: We assessed human milk intakes of Thai infants during the first 6 months comparing exclusive (EBF), predominant (PBF) and partial (PartBF) breastfeeding.
Methods: One-hundred and ten apparently healthy Thai lactating mother-infant pairs were followed from birth. Human milk intakes were determined at 6 weeks, 3 and 6 months, using the DTM method. Daily energy and protein intakes were assessed using 3-day non-consecutive 24-hour recalls. Socio-demographic characteristics were collected using a questionnaire. For comparisons among breastfeeding practices, one-way ANOVA with Tukey's post hoc test was used for normally distributed data, or Kruskal-Wallis Test with Mann-Whitney U Test for not normally distributed data.
Detailed description
Human milk intakes were comparable between the EBF and PBF infants during the first 6 months, and provided the sole source of energy and protein; infant formula largely replaced breast milk among PartBF infants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exclusive breastfeeding (EBF) | – | Other: no interventionprovision of breast milk only, allowing only receiving oral rehydration salts (ORS), drops and syrups (vitamins, minerals, medicines) as necessary |
| Predominant breastfeeding (PBF) | – | Other: no interventionproviding breast milk plus other liquids (water and water-based drinks, fruit juice) and ORS, drops and syrups (vitamins, minerals, medicines) |
| Partial breastfeeding (PartBF) | – | Other: no interventionprovision of breast milk plus infant formula or cow milk or other solid/semi-solid complementary foods |
Who may qualify
- Ages
- 2 weeks to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The mother-infant pairs were recruited at the Ratchaburi hospital and Health promoting hospital, Health promotion center region 5, both situated in Ratchaburi province, central Thailand.
Key inclusion criteria (6 listed)
- Apparently healthy women aged 20-35 year
- Had pre-pregnancy BMI in the normal range (18.5-25 kg/m2)
- Planned to breastfeed their baby for at least 6 months
- Being full term infants (gestational age 37-42 weeks) and singleton
- Had normal birth weight (2,500 - 4,000 g)
Key exclusion criteria (3 listed)
- Infant: preterm; twin; low and high birth weight; congenital diseases
- Mother: chronic diseases needed to get medicine and treatment; underweight and obesity
- Mother and baby did not stay together throughout 12 months of infant age
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 |
|---|---|---|
| no interventionAlso: Observational studyMeasure human intake using stable isotope technique | Other | Exclusive breastfeeding (EBF), Partial breastfeeding (PartBF), Predominant breastfeeding (PBF) |
Primary outcome
Human milk intake of Thai breastfed infants during the first 6 months using the dose-to-mother deuterium dilution method
Time frame: 6 months
assessed human milk intakes of Thai infants during the first 6 months comparing exclusive (EBF), predominant (PBF) and partial (PartBF) breastfeeding
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 16 Jul 2019.
- Background: PubMed 30107466Vogelezang S, Santos S, van der Beek EM, Abrahamse-Berkeveld M, Duijts L, van der Lugt A, Felix JF, Jaddoe VWV. Infant breastfeeding and childhood general, visceral, liver, and pericardial fat measures assessed by magnetic resonance imaging. Am J Clin Nutr. 2018 Oct 1;108(4):722-729. doi: 10.1093/ajcn/nqy137.
- Derived from this study: 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.
- 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.
WANABHORN TONGCHOM, PhD principal investigator
Institute of Nutrition
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Feeding, 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 3 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 16 Jul 2019. 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?
Human milk intake of Thai breastfed infants during the first 6 months using the dose-to-mother deuterium dilution method (time frame: 6 months). 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 NCT04020640, 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 16 Jul 2019.