Cholestasis in Extreme Low Birth Weight Infants (ELBW)
|ClinicalTrials.gov Identifier: NCT01164878|
Recruitment Status : Completed
First Posted : July 19, 2010
Last Update Posted : October 3, 2016
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 or disease|
|Study Type :||Observational|
|Actual Enrollment :||122 participants|
|Official Title:||Cholestasis in Extreme Low Birth Weight Infants (ELBW) - Possible Influences of a Change in Nutrition Policy|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||July 2010|
ELBW infants before change of feeding policy
ELBW infants after change of feeding policy
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01164878
|Principal Investigator:||Nadja Haiden, MD||Medical University Vienna|
|Principal Investigator:||Andreas Repa, MD||Medical University Vienna|