Text Size

Cholestasis in Extreme Low Birth Weight Infants (ELBW)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nadja Haiden,MD, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01164878
First received: July 12, 2010
Last updated: October 19, 2012
Last verified: October 2012
History of Changes
  Purpose

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
Cholestasis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Cholestasis in Extreme Low Birth Weight Infants (ELBW) - Possible Influences of a Change in Nutrition Policy

Resource links provided by NLM:

MedlinePlus related topics: Birth Weight
U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    Conjugated Bilirubin > 1.5 mg/dl at two measurements


Secondary Outcome Measures:
  • Growth [ Time Frame: At study entry (after birth, 0 weeks) and discharge (i.e. at an average of 12 weeks) ] [ Designated as safety issue: No ]
    Body weight, head circumference and heel-crown length assessed at birth and at discharge from or transfer to another hospital


Enrollment: 122
Study Start Date: January 2010
Study Completion Date: July 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Before
ELBW infants before change of feeding policy
After
ELBW infants after change of feeding policy

  Eligibility

Ages Eligible for Study:   up to 1 Hour
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Preterm Infants below 1000 Gram birth weight

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01164878

Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Nadja Haiden, MD Medical University Vienna
Principal Investigator: Andreas Repa, MD Medical University Vienna
  More Information

No publications provided

Responsible Party: Nadja Haiden,MD, PD Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01164878     History of Changes
Other Study ID Numbers: MUVNeo-1
Study First Received: July 12, 2010
Last Updated: October 19, 2012
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
Cholestasis
Liver damage
Parenteral Nutrition
Aggressive Nutrition
 Preterm
Extreme low birth weight infant
Parenteral Nutrition Associated Cholestasis

Additional relevant MeSH terms:
Birth Weight
Cholestasis
Body Weight
Signs and Symptoms
 Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013