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Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis

NCT ID: NCT01555957

Last Updated: 2020-12-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2019-01-31

Brief Summary

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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

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Conditions

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Parenteral Nutrition Associated Cholestasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
The care taker team provided daily weight to the research pharmacist for calculating the dose of the lipid according to the assignment and then calculated the rate of administration over 18 to 24 hours depending on the volume. The rate and dose was masked to the investigators and participants.

Study Groups

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low dose intravenous lipids

Group Type EXPERIMENTAL

intravenous lipid

Intervention Type DRUG

intravenous given daily for 6 weeks

high dose of intravenous lipids

Group Type PLACEBO_COMPARATOR

intravenous lipid

Intervention Type DRUG

intravenous given daily for 6 weeks

Interventions

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intravenous lipid

intravenous given daily for 6 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

72 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sanjiv Amin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Kunal Gupta, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

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University of Rochester

Rochester, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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URochester

Identifier Type: -

Identifier Source: org_study_id