Cholestasis in Extreme Low Birth Weight Infants (ELBW)

Cholestasis in Extreme Low Birth Weight Infants (ELBW) - Possible Influences of a Change in Nutrition Policy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01164878

Enrollment

122

Registered

2010-07-19

Start date

2010-01-31

Completion date

2010-07-31

Last updated

2016-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholestasis

Keywords

Cholestasis, Liver damage, Parenteral Nutrition, Aggressive Nutrition, Preterm, Extreme low birth weight infant, Parenteral Nutrition Associated Cholestasis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 1 Hours

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

Design outcomes

Primary

Measure	Time frame	Description
Cholestasis	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

Measure	Time frame	Description
Growth	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

Outcome results