NCT01164878

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 19, 2010

Completed
Last Updated

October 3, 2016

Status Verified

September 1, 2016

Enrollment Period

5 months

First QC Date

July 12, 2010

Last Update Submit

September 30, 2016

Conditions

Cholestasis

Keywords

CholestasisLiver damageParenteral NutritionAggressive NutritionPretermExtreme low birth weight infantParenteral Nutrition Associated Cholestasis

Outcome Measures

Primary Outcomes (1)

  • Cholestasis

    Conjugated Bilirubin \> 1.5 mg/dl at two measurements

    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 (1)

  • Growth

    At study entry (after birth, 0 weeks) and discharge (i.e. at an average of 12 weeks)

Study Arms (2)

Before

ELBW infants before change of feeding policy

After

ELBW infants after change of feeding policy

Eligibility Criteria

AgeUp to 1 Hour
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Preterm Infants below 1000 Gram birth weight

You may qualify if:

  • ELBW infants below 1000 Gram birth weight
  • Born in house between January 2005 - December 2006 ("before") and July 2007- June 2009 ("after")

You may not qualify if:

  • signs of cholestasis at birth
  • Death or transfer before 28 Days of life
  • Diseases associated with Cholestasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 27688976BACKGROUND

Related Links

MeSH Terms

Conditions

CholestasisHyperphagiaPremature Birth

Condition Hierarchy (Ancestors)

Bile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Nadja Haiden, MD

    Medical University Vienna

    PRINCIPAL INVESTIGATOR

  • Andreas Repa, MD

    Medical University Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr.

Study Record Dates

First Submitted

July 12, 2010

First Posted

July 19, 2010

Study Start

January 1, 2010

Primary Completion

June 1, 2010

Study Completion

July 1, 2010

Last Updated

October 3, 2016

Record last verified: 2016-09