- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01164878
Cholestasis in Extreme Low Birth Weight Infants (ELBW)
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
Conditions
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Investigators
- Principal Investigator: Andreas Repa, MD, Medical University Vienna
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MUVNeo-1
Plan for Individual participant data (IPD)
Study Data/Documents
-
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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