Trial · NCT06048614
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| 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 |
| Other | Measure serum levels of GABA 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 level of Propionate in µM | Before 36 weeks of corrected age of discharge of the infant | Use Short Chain Fatty Acid Panel to measure |
| Other | Measure level of Butyrate in µM | Before 36 weeks of corrected age of discharge of the infant | Use Short Chain Fatty Acid Panel to measure |
| Other | Measure level of Acetate in µM | Before 36 weeks of corrected age of discharge of the infant | Use Short Chain Fatty Acid Panel to measure |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT06048614/registered