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Completed

NCT Number: NCT01164878

Cholestasis in Extreme Low Birth Weight Infants (ELBW)

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.

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Key information

Conditions

Cholestasis Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases Female Urogenital Diseases and Pregnancy Complications Hyperphagia Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Signs and Symptoms Signs and Symptoms, Digestive Urogenital Diseases

Age range

Up to 1 hour

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jul 19, 2010
Registry last updated
Oct 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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