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OpenTrials
Completed

NCT Number: NCT01555957

Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis

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

Completed

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Key information

Conditions

Parenteral Nutrition Associated Cholestasis

Age range

Up to 72 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Rochester

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • If does not need TPN by 72 hours;
  • Direct hyperbilirubinemia within the first 72 hours after birth;
  • TORCH infections (Toxoplasmosis, CMV, Herpes, Rubella, HIV, etc);
  • Biliary tract disorders leading to direct hyperbilirubinemia;
  • Known metabolic disorders that may be associated with direct hyperbilirubinemia- such as Galactosemia, α-1 antitrypsin deficiency, etc

Treatment and study plan

intravenous lipid

Drug

intravenous given daily for 6 weeks

Primary outcomes

  1. Number of Participants With Parenteral Nutrition Associated Cholestasis

    Time frame: 7 weeks

    Defined as direct bilirubin ≥ 2mg/dl developing within one week of the completion of 6 week randomization period

Secondary outcomes

  1. Mean Rate of Change in Direct Bilirubin

    Time frame: baseline, weeks 1, 2, 3, 4, 5 and 6

    Amount of direct (conjugated) bilirubin was measured from sera samples.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2018
Study completion
2019
First posted
Mar 16, 2012
Registry last updated
Dec 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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