Cholestasis in Extreme Low Birth Weight Infants (ELBW)

September 30, 2016 updated by: Nadja Haiden,MD, Medical University of Vienna

Cholestasis in Extreme Low Birth Weight Infants (ELBW) - Possible Influences of a Change in Nutrition Policy

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

122

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 hour (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Preterm Infants below 1000 Gram birth weight

Description

Inclusion Criteria:

  • ELBW infants below 1000 Gram birth weight
  • Born in house between January 2005 - December 2006 ("before") and July 2007- June 2009 ("after")

Exclusion Criteria:

  • signs of cholestasis at birth
  • Death or transfer before 28 Days of life
  • Diseases associated with Cholestasis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Before
ELBW infants before change of feeding policy
After
ELBW infants after change of feeding policy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cholestasis
Time Frame: Assessment of bilirubin levels at least every second week from birth (0 weeks) to discharge (i.e. up to an average of 12 weeks)
Conjugated Bilirubin > 1.5 mg/dl at two measurements
Assessment of bilirubin levels at least every second week from birth (0 weeks) to discharge (i.e. up to an average of 12 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Growth
Time Frame: At study entry (after birth, 0 weeks) and discharge (i.e. at an average of 12 weeks)
Body weight, head circumference and heel-crown length assessed at birth and at discharge from or transfer to another hospital
At study entry (after birth, 0 weeks) and discharge (i.e. at an average of 12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Andreas Repa, MD, Medical University Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

June 1, 2010

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

July 12, 2010

First Submitted That Met QC Criteria

July 16, 2010

First Posted (ESTIMATE)

July 19, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 3, 2016

Last Update Submitted That Met QC Criteria

September 30, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Individual Participant Data Set
    Information comments: SPSS Data Set for Analysis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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