Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Parenteral Nutrition Associated Cholestasis |
6; 6 | 0.94 |
| SECONDARY Mean Rate of Change in Direct Bilirubin |
0.16; 0.19 | 0.0005 sig |
Eligibility Criteria
Inclusion Criteria
All neonates ≥ 34 weeks gestational age with major GI surgical disorders (Gastroschisis, omphalocele, volvulus, trachea-esophageal fistula, duodenal atresia, jejunal atresia, ileal atresia, hirschsprung's disease, anorectal malformation, intestinal obstruction, and GI perforations) requiring surgery admitted to our NICU within first 72 hours will be eligible for this study
Exclusion Criteria
- If does not need TPN by 72 hours;
- Direct hyperbilirubinemia within the first 72 hours after birth;
- TORCH infections (Toxoplasmosis, CMV, Herpes, Rubella, HIV, etc);
- Biliary tract disorders leading to direct hyperbilirubinemia;
- Known metabolic disorders that may be associated with direct hyperbilirubinemia- such as Galactosemia, α-1 antitrypsin deficiency, etc
Data sourced from ClinicalTrials.gov (NCT01555957). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.