Clinical trial NCT01164878: Cholestasis in Extreme Low Birth Weight Infants (ELBW)
Official title: Cholestasis in Extreme Low Birth Weight Infants (ELBW) - Possible Influences of a Change in Nutrition Policy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholestasis
Keywords: Cholestasis
Liver damage
Parenteral Nutrition
Aggressive Nutrition
Preterm
Extreme low birth weight infant
Parenteral Nutrition Associated Cholestasis
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2010-07-19
Enrollment: 122
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Preterm Infants below 1000 Gram birth weight

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.


Eligibility 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

Primary outcomes:
measure: Cholestasis
timeFrame: 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 outcomes:
measure: Growth
timeFrame: At study entry (after birth, 0 weeks) and discharge (i.e. at an average of 12 weeks)
Other outcomes:
Locations:
Study officials:
affiliation: Medical University Vienna
name: Nadja Haiden, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University Vienna
name: Andreas Repa, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Repa A, Lochmann R, Unterasinger L, Weber M, Berger A, Haiden N. Aggressive nutrition in extremely low birth weight infants: impact on parenteral nutrition associated cholestasis and growth. PeerJ. 2016 Sep 20;4:e2483. doi: 10.7717/peerj.2483. eCollection 2016.