Trial · NCT06048614
Saline Enema Administration in Meconium Obstruction of Prematurity and Impact on the Resolution, Feeds, Microbiome, and Gut-brain Axis.
NCT06048614, Not applicable, Recruiting, KK Women's and Children's Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Saline Enema Administration in Meconium Obstruction of Prematurity and Impact on the Resolution, Feeds, Microbiome, and Gut-brain Axis. Trials, record NCT06048614. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06048614
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Saline Enema Administration in Meconium Obstruction of Prematurity and Impact on the Resolution, Feeds, Microbiome, and Gut-brain Axis.
- NCT number
- NCT06048614
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 95 participants, estimated
- Lead sponsor
- KK Women's and Children's Hospital
- Conditions
- Meconium Obstruction of Prematurity
- Interventions
- Saline Enema (SE), Glycerin Suppository
- First posted
- 2023-09-21
- Last updated
- 2025-05-23
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to reach full enteral feeds in days | Before 36 weeks of corrected age of discharge of the infant | Time to reach full enteral feeds is measured from birth to the time infant reaches full oral milk feeds. Full oral milk feed is defined as milk volume of 110ml/kg/day. The total parenteral nutrition is discontinued when infant reaches milk feed volume of 110ml/kg/day. Rationale: SE loosens the thick and sticky meconium by saline absorption and triggers effective and strong peristaltic contractions, thereby leading to the evacuation of meconium from the gut. The evacuation of meconium leads to the resolution of the gut obstruction, thereby enhancing feed tolerance in premature infants with meconium obstruction of prematurity. |
| Secondary | Rate of treatment failure | Before 36 weeks of corrected age of discharge of the infant | Treatment failure is defined as the need to use additional treatment measures, apart from the study intervention to resolve MOP in the study cohort. |
| Secondary | Rate of (a) Culture positive sepsis (b) Necrotising enterocolitis. | Before 36 weeks of corrected age of discharge of the infant | Rationale: If twice daily SE leads to the shortening of time to reach full enteral feeds, resolution of MOP, and promote friendly bacteria microbiome, then it has the potential to reduce NICU stay, risk of necrotising enterocolitis, risk of sepsis, duration of total parenteral nutrition, duration of PICC and overall cost of care. |
| Secondary | Duration in days of (a) ICU stay (b) Total parenteral nutrition (c) PICC days. | Before 36 weeks of corrected age of discharge of the infant | Rationale: If twice daily SE leads to the shortening of time to reach full enteral feeds, resolution of MOP, and promote friendly bacteria microbiome, then it has the potential to reduce NICU stay, risk of necrotising enterocolitis, risk of sepsis, duration of total parenteral nutrition, duration of PICC and overall cost of care. |
| Secondary | Overall cost of care calculated in SGD at the time of discharge | Before 36 weeks of corrected age of discharge of the infant | Rationale: If twice daily SE leads to the shortening of time to reach full enteral feeds, resolution of MOP, and promote friendly bacteria microbiome, then it has the potential to reduce NICU stay, risk of necrotising enterocolitis, risk of sepsis, duration of total parenteral nutrition, duration of PICC and overall cost of care. |
| Other | Identification and quantification of bacteria from meconium/stool samples by DNA sequencing and analysis of top 50 bacteria Genus | Before 36 weeks of corrected age of discharge of the infant | Bacteria are identified from meconium/stools samples, collected at birth and weekly interval till discharge or 36 weeks of gestation |
| Other | To measure the serum level of IL 6 in pg/ml | Before 36 weeks of corrected age of discharge of the infant | Use Olink Target 48 platform to measure Rationale: To explore the relationship between gut microbiome and gut-brain axis |
| Other | To measure the serum level of neurotransmitters noradrenaline in pg/L | Before 36 weeks of corrected age of discharge of the infant | Use Norepinephrine ELISA Kit from abcam to measure |
| Other | Measure serum levels of dopamine in arbitrary units (peak area of analyte divided by peak area of an internal standard) | Before 36 weeks of corrected age of discharge of the infant | Use Norepinephrine ELISA Kit from abcam to measure |
| Other | Measure serum levels of serotonin in arbitrary units (peak area of analyte divided by peak area of an internal standard) | Before 36 weeks of corrected age of discharge of the infant | Use Norepinephrine ELISA Kit from abcam to measure |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers21
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06048614
GET https://conductscience.org/api/trials/v1/NCT06048614/papers?page=2