Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT01555957
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:
1. If does not need TPN by 72 hours;
2. Direct hyperbilirubinemia within the first 72 hours after birth;
3. TORCH infections (Toxoplasmosis, CMV, Herpes, Rubella, HIV, etc);
4. Biliary tract disorders leading to direct hyperbilirubinemia;
5. Known metabolic disorders that may be associated with direct hyperbilirubinemia- such as Galactosemia, α-1 antitrypsin deficiency, etc
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
72 Hours
Study:
NCT01555957
Study Brief:
Protocol Section:
NCT01555957