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Cholestasis in Extreme Low Birth Weight Infants (ELBW)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01164878
Recruitment Status : Completed
First Posted : July 19, 2010
Last Update Posted : October 3, 2016
Information provided by (Responsible Party):
Nadja Haiden,MD, Medical University of Vienna

Brief 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.

Condition or disease

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Study Type : Observational
Actual Enrollment : 122 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Cholestasis in Extreme Low Birth Weight Infants (ELBW) - Possible Influences of a Change in Nutrition Policy
Study Start Date : January 2010
Actual Primary Completion Date : June 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

ELBW infants before change of feeding policy
ELBW infants after change of feeding policy

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Hour   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Preterm Infants below 1000 Gram birth weight

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01164878

Sponsors and Collaborators
Medical University of Vienna
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Principal Investigator: Nadja Haiden, MD Medical University Vienna
Principal Investigator: Andreas Repa, MD Medical University Vienna
Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the site
SPSS Data Set for Analysis

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Responsible Party: Nadja Haiden,MD, PD Dr., Medical University of Vienna Identifier: NCT01164878    
Other Study ID Numbers: MUVNeo-1
First Posted: July 19, 2010    Key Record Dates
Last Update Posted: October 3, 2016
Last Verified: September 2016
Keywords provided by Nadja Haiden,MD, Medical University of Vienna:
Liver damage
Parenteral Nutrition
Aggressive Nutrition
Extreme low birth weight infant
Parenteral Nutrition Associated Cholestasis
Additional relevant MeSH terms:
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Birth Weight
Body Weight
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases