Clinical trial NCT06950658: Breastfeeding Success and Time of First Meconium Passage
Official title: Breastfeeding Success in Term Newborn and Time of First Meconium Passage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Meconium
Breastfeeding
Keywords: Breastfeeding
Breast milk
meconium passage
newborn
infant
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 59
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Timing of the first meconium passage
timeFrame: 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)
measure: LATCH score
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Acıbadem University
state: Ataşehir
Study officials:
References:
citation: 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.
citation: Feldman-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.
citation: Ezomike 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.
citation: Bekkali 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.