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Cholestasis in Extreme Low Birth Weight Infants (ELBW)

NCT01164878 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 122

Last updated 2016-10-03

No results posted yet for this study

Summary

Parenteral nutrition associated liver disease (PNALD) in preterm neonates is characterized by early occurrence of intrahepatic cholestasis (parenteral nutrition associated cholestasis (PNAC).

Extreme low birth weight infants (ELBW, birth weight \< 1000 g) are at increased risk for development of PNAC.

Important factors implicated in the aetiology of PNAC are high caloric parenteral nutrition using amino acids or dextrose, but also intravenous lipids and infections in particular necrotizing enterocolitis (NEC).

Due to a change of paradigm a more aggressive nutrition with early use of parenteral amino acids/lipids and early fortification of mothers milk or alternatively high caloric preterm formula is warranted. Accordingly - in line with the existing expert opinion and evidence - the feeding policy at the neonatal care units of our hospital was adapted.

Evidence exists that PNAC might be caused by the use of high concentrations of amino acids and lipids in parenteral nutrition. Furthermore NEC is associated with high osmotic feeds. Therefore the incidence of PNAC might be increased directly and indirectly after introducing the new feeding policy.

The investigators therefore aim at retrospectively investigating the incidence of PNAC before and after introduction of a feeding policy of "aggressive nutrition" for ELBW infants.

Conditions

  • Cholestasis

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Nadja Haiden, MD · Medical University Vienna

  • Andreas Repa, MD · Medical University Vienna

Eligibility

Max Age
1 Hour
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-06-30
Completion
2010-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01164878 on ClinicalTrials.gov