Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis

Phase 3

Completed

• Conditions: Parenteral Nutrition Associated Cholestasis
• Interventions: Drug: intravenous lipid

• Registration Number: NCT01555957
• Lead Sponsor: University of Rochester

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-03-14
• Study First Submitted QC: 2012-03-14
• Study First Posted: 2012-03-16
• Primary Completion: 2018-10-30
• Study Completion: 2019-01-31
• Results First Submitted: 2020-11-05
• Status Verified: 2020-12
• Results First Submitted QC: 2020-12-02
• Last Update Submitted: 2020-12-02
• Results First Posted: 2020-12-03
• Last Update Posted: 2020-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low dose intravenous lipids	intravenous lipid	-
high dose of intravenous lipids	intravenous lipid	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Parenteral Nutrition Associated Cholestasis	7 weeks	Defined as direct bilirubin ≥ 2mg/dl developing within one week of the completion of 6 week randomization period

Secondary Outcome Measures

Name	Time	Method
Mean Rate of Change in Direct Bilirubin	baseline, weeks 1, 2, 3, 4, 5 and 6	Amount of direct (conjugated) bilirubin was measured from sera samples.

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States