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Completed

NCT Number: NCT06950658

Breastfeeding Success and Time of First Meconium Passage

To investigate the relationship between breastfeeding success and the time of first meconium passage in term newborns.

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Key information

Age range

1 day–3 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Acıbadem University

Istanbul, Ataşehir, 34750, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study title

Breastfeeding Success in Term Newborn and Time of First Meconium Passage

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 30, 2025
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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