NCT05959460

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 25, 2023

Completed
Last Updated

April 2, 2024

Status Verified

March 1, 2024

Enrollment Period

3 years

First QC Date

July 16, 2023

Last Update Submit

March 30, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Non-milk oral intake

    Quantity of non-milk oral intake (g)

    Jan 2016 - Dec 2020

  • Human milk intake

    Quantity of milk intake (g)

    Jan 2016 - Dec 2020

Secondary Outcomes (9)

  • Body composition of mothers: total body water

    Jan 2016 - Dec 2020

  • Body composition of mothers: fat free mass

    Jan 2016 - Dec 2020

  • Body composition of mothers: fat mass

    Jan 2016 - Dec 2020

  • Weight of infants

    Jan 2016 - Dec 2020

  • length of infants

    Jan 2016 - Dec 2020

  • +4 more secondary outcomes

Study Arms (1)

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

Interventions

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

1

Eligibility Criteria

Age3 Months - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 32799695BACKGROUND
  • 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.

    PMID: 29849742BACKGROUND

Related Links

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Tippawan Pongcharoen, PhD

    Mahidol U

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Dr.

Study Record Dates

First Submitted

July 16, 2023

First Posted

July 25, 2023

Study Start

January 1, 2016

Primary Completion

December 31, 2018

Study Completion

January 1, 2020

Last Updated

April 2, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share