NCT06950658

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

December 12, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 30, 2025

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

3 months

First QC Date

April 21, 2025

Last Update Submit

April 27, 2025

Conditions

Keywords

BreastfeedingBreast milkmeconium passagenewborninfant

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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.

Study Arms (1)

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).

Eligibility Criteria

Age1 Day - 3 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acıbadem University

Istanbul, Ataşehir, 34750, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 27330542BACKGROUND
  • 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.

    PMID: 32161111BACKGROUND
  • 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.

    PMID: 31452849BACKGROUND
  • 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.

    PMID: 18285377BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

April 21, 2025

First Posted

April 30, 2025

Study Start

December 12, 2023

Primary Completion

March 22, 2024

Study Completion

March 22, 2024

Last Updated

April 30, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations