Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis

Parenteral Nutrition Associated Cholestasis Clinical Trial

Official title:

Effect of Lipid Intake on Direct Hyperbilirubinemia in Late Preterm and Term Infants With Gastrointestinal Surgical Problems.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01555957
• Other study ID #: URochester
• Status: Completed
• Phase: Phase 3
• Start date: February 2012
• Est. completion date: January 31, 2019

Study information

• Verified date: December 2020
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 31, 2019
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 72 Hours

Eligibility

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, a-1 antitrypsin deficiency, etc

Related Conditions & MeSH terms

• Cholestasis
• Parenteral Nutrition Associated Cholestasis

Intervention

Drug:
• intravenous lipid
intravenous given daily for 6 weeks

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Parenteral Nutrition Associated Cholestasis	Defined as direct bilirubin = 2mg/dl developing within one week of the completion of 6 week randomization period	7 weeks
Secondary	Mean Rate of Change in Direct Bilirubin	Amount of direct (conjugated) bilirubin was measured from sera samples.	baseline, weeks 1, 2, 3, 4, 5 and 6