Breastfeeding Success and Time of First Meconium Passage

April 27, 2025 updated by: Zehra Kan Onturk, Acibadem University

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

59

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Ataşehir
      • İstanbul, Ataşehir, Turkey, 34750
        • Acıbadem University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • Healthy term newborns (≥37 weeks gestation) who were exclusively breastfeed

Exclusion Criteria:

  • Newborns who received any feeding other than direct breastfeeding (e.g., bottle, cup, etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timing of the first meconium passage
Time Frame: 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)
Newborns were observed from birth until discharge. During this observation, when the first meconium passage occurred, the timing of meconium passage was recorded.
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
Time Frame: 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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acibadem University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2023

Primary Completion (Actual)

March 22, 2024

Study Completion (Actual)

March 22, 2024

Study Registration Dates

First Submitted

April 21, 2025

First Submitted That Met QC Criteria

April 27, 2025

First Posted (Actual)

April 30, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 27, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ATADEK 2023-16/554

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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