MeconiumNCT06950658
Breastfeeding Success and Time of First Meconium Passage
An observational study of Meconium and Breastfeeding, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
To investigate the relationship between breastfeeding success and the time of first meconium passage in term newborns. Read more about this study
- Who is it for?
- Ages 1 day to 3 daysHealthy volunteers can take part
- Conditions the study is for
- Meconium, Breastfeeding
- How many people
- 59 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Dec 2023to 22 Mar 2024
- Phase
- Observational
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 1 day to 3 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population consisted of all term newborns monitored in the postnatal period, while the sample comprised newborns who met the inclusion criteria and were followed in the Neonatal Care Unit.
Who may be able to join
- Healthy term newborns (≥37 weeks gestation) who were exclusively breastfeed
Who cannot join
- Newborns who received any feeding other than direct breastfeeding (e.g., bottle, cup, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Breastfeeding Success in Term Newborn and Time of First Meconium Passage
To investigate the relationship between breastfeeding success and the time of first meconium passage in term newborns.
Read the detailed description
The timing of the first meconium passage in neonates is a useful indicator of distal colon function. Delayed passage may signal congenital distal bowel dysfunctions such as hirschsprung disease (HD), anorectal malformations, distal intestinal atresia, prematurity, or hypothyroidism. Several factors may influence the timing of the first meconium passage, including gestational age, birth weight, sex, mode of delivery, and presence of respiratory distress. Another significant factor is breastfeeding. Effective breastfeeding is known to contribute to the maturation of the gut microbiota and has long-term positive outcomes for both mother and infant. However, the literature lacks studies examining the relationship between breastfeeding and the timing of meconium passage.This study aimed to investigate the relationship between breastfeeding success and the timing of first meconium passage in term newborns. The following hypotheses were tested: (a) There is a relationship between breastfeeding success and the timing of meconium passage in term newborns; (b) Term newborns with higher breastfeeding success will pass meconium earlier.
- Conditions
- Meconium, Breastfeeding
- Keywords
- Breastfeeding, Breast milk, meconium passage, newborn, infant
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Term infants followed for breastfeeding success and time of first meconium passage | Data on the timing of first meconium passage to newborns were obtained and recorded by observing infants until discharge. Data on breastfeeding success in all their mother was assessed using the LATCH Breastfeeding Assessment Tool at three different time points: during the first breastfeeding session (0-1 hours), on day 1 (1-24 hours), and on day 2 (24-48 hours). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timing of the first meconium passage
Newborns were observed from birth until discharge. During this observation, when the first meconium passage occurred, the timing of meconium passage was recorded.
Measured: The difference from the time of birth to the first observed meconium passage during hospitalization, assessed up to the time of discharge (up to 72 hours)
LATCH score
Breastfeeding success in all newborns was assessed using the LATCH Breastfeeding Assessment Tool at three different time points: during the first breastfeeding session (0-1 hours), on day 1 (1-24 hours), and on day 2 (24-48 hours). The LATCH Breastfeeding Assessment Tool was developed in 1993 by Deborah Jensen and Sheila Wallace. The Turkish adaptation and validation of the tool were conducted by Yenal and Okumuş. Modeled after the Apgar scoring system, this tool was designed to objectively evaluate breastfeeding success, identify potential issues, and establish a standardized language among healthcare professionals. The scale consists of five criteria, each scored from 0 to 2, for a total score ranging from 0 to 10. Higher LATCH scores indicate greater breastfeeding success.
Measured: LATCH score assessed first breastfeeding, on day 1 (1-24 hours), and on day 2 (24-48 hours). The change in these time intervals will be assessed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start12 Dec 2023
- Primary completion22 Mar 2024
- Study completion22 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MeconiumStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra Kan Onturk, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950658
- Sponsor's protocol ID
- ATADEK 2023-16/554
- Status last verified
- Apr 2025
- First submitted
- 21 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sharma IK, Byrne A. Early initiation of breastfeeding: a systematic literature review of factors and barriers in South Asia. Int Breastfeed J. 2016 Jun 18;11:17. doi: 10.1186/s13006-016-0076-7. eCollection 2016.
PubMed 27330542Feldman-Winter L, Kellams A, Peter-Wohl S, Taylor JS, Lee KG, Terrell MJ, Noble L, Maynor AR, Meek JY, Stuebe AM. Evidence-Based Updates on the First Week of Exclusive Breastfeeding Among Infants >/=35 Weeks. Pediatrics. 2020 Apr;145(4):e20183696. doi: 10.1542/peds.2018-3696. Epub 2020 Mar 11.
PubMed 32161111Ezomike UO, Ugwu EO, Ezomike NE, Eke CB, Ekenze SO. Evaluation of Impact of Perinatal Factors on Time to First Meconium Passage in Nigerian Neonates. Malawi Med J. 2019 Jun;31(2):150-154. doi: 10.4314/mmj.v31i2.8.
PubMed 31452849Bekkali N, Hamers SL, Schipperus MR, Reitsma JB, Valerio PG, Van Toledo L, Benninga MA. Duration of meconium passage in preterm and term infants. Arch Dis Child Fetal Neonatal Ed. 2008 Sep;93(5):F376-9. doi: 10.1136/adc.2008.138024. Epub 2008 Feb 19.
PubMed 18285377