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
- Are there results?
- None posted in the registry
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.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breastfeeding Success in Term Newborn and Time of First Meconium Passage
- ClinicalTrials.gov ID
- NCT06950658
- Acronym / sponsor ID
- ATADEK 2023-16/554
- Conditions
- Meconium, Breastfeeding
- Keywords
- Breastfeeding, Breast milk, meconium passage, newborn, infant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 22 Mar 2024 (actual)
- Study completion
- 22 Mar 2024 (actual)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 1 day to 3 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- Healthy term newborns (≥37 weeks gestation) who were exclusively breastfeed
Key exclusion criteria (1 listed)
- Newborns who received any feeding other than direct breastfeeding (e.g., bottle, cup, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Results publication: PubMed 27330542Sharma 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.
- Results publication: PubMed 32161111Feldman-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.
- Results publication: PubMed 31452849Ezomike 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.
- Results publication: PubMed 18285377Bekkali 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meconium and Breastfeeding, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06950658, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.