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Cholestasis in Extreme Low Birth Weight Infants (ELBW)

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Medical University of Vienna

Status

Completed

Conditions

Cholestasis

Study type

Observational

Funder types

Other

Identifiers

NCT01164878
MUVNeo-1

Details and patient eligibility

About

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.

Enrollment

122 patients

Sex

All

Ages

Under 1 hour old

Volunteers

No Healthy Volunteers

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

Trial design

122 participants in 2 patient groups

Before
Description:
ELBW infants before change of feeding policy
After
Description:
ELBW infants after change of feeding policy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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