Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis

University of Rochester

Status and phase: Completed; Phase 3

Conditions: Parenteral Nutrition Associated Cholestasis

Treatments: Drug: intravenous lipid

Study type: Interventional

Funder types: Other

Identifiers

NCT01555957

URochester

Details and patient eligibility

About

The Investigators hypothesize that increased cumulative amount of lipid intake causes PNAC in late preterm and term neonates with major GI surgical disorders

Enrollment: 40 patients

Sex: All

Ages: Under 72 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

low dose intravenous lipids

Experimental group

Treatment:

Drug: intravenous lipid

high dose of intravenous lipids

Placebo Comparator group

Treatment:

Drug: intravenous lipid