CholestasisNCT01164878
Cholestasis in Extreme Low Birth Weight Infants (ELBW)
An observational study of Cholestasis, run by Medical University of Vienna.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 1 hour
- Conditions the study is for
- Cholestasis
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jul 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 hour
- All sexes
- No healthy volunteers
- Child
Study population: Preterm Infants below 1000 Gram birth weight
Who may be able to join
- ELBW infants below 1000 Gram birth weight
- Born in house between January 2005 - December 2006 ("before") and July 2007- June 2009 ("after")
Who cannot join
- signs of cholestasis at birth
- Death or transfer before 28 Days of life
- Diseases associated with Cholestasis
About this study
Official title: Cholestasis in Extreme Low Birth Weight Infants (ELBW) - Possible Influences of a Change in Nutrition Policy
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.
Read more
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.
- Conditions
- Cholestasis
- Keywords
- Cholestasis, Liver damage, Parenteral Nutrition, Aggressive Nutrition, Preterm, Extreme low birth weight infant, Parenteral Nutrition Associated Cholestasis
- Medical subject headings
- Cholestasis, Hyperphagia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Before | ELBW infants before change of feeding policy | |
| After | ELBW infants after change of feeding policy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cholestasis
Conjugated Bilirubin > 1.5 mg/dl at two measurements
Measured: 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
Body weight, head circumference and heel-crown length assessed at birth and at discharge from or transfer to another hospital
Measured: At study entry (after birth, 0 weeks) and discharge (i.e. at an average of 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CholestasisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadja Haiden,MD, Medical University of Vienna
- Investigators
- Nadja Haiden, MD, Principal investigator, Medical University of ViennaAndreas Repa, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01164878
- Sponsor's protocol ID
- MUVNeo-1
- Status last verified
- Sep 2016
- First submitted
- 12 Jul 2010
- Last updated
- 3 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27688976
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cholestasis in Extreme Low Birth Weight Infants (ELBW) - Possible Influences of a Change in Nutrition Policy
- ClinicalTrials.gov ID
- NCT01164878
- Acronym / sponsor ID
- MUVNeo-1
- Conditions
- Cholestasis
- Keywords
- Cholestasis, Liver damage, Parenteral Nutrition, Aggressive Nutrition, Preterm, Extreme low birth weight infant, Parenteral Nutrition Associated Cholestasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 19 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before | – | –ELBW infants before change of feeding policy |
| After | – | –ELBW infants after change of feeding policy |
Who may qualify
- Ages
- Up to 1 hour
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm Infants below 1000 Gram birth weight
Key inclusion criteria (2 listed)
- ELBW infants below 1000 Gram birth weight
- Born in house between January 2005 - December 2006 ("before") and July 2007- June 2009 ("after")
Key exclusion criteria (3 listed)
- signs of cholestasis at birth
- Death or transfer before 28 Days of life
- Diseases associated with Cholestasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Growth
Time frame: At study entry (after birth, 0 weeks) and discharge (i.e. at an average of 12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2016.
- Background: PubMed 27688976Repa 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadja Haiden, MD principal investigator
Medical University of Vienna
Andreas Repa, MD principal investigator
Medical University of Vienna
Questions about this trial
What is this clinical trial studying?
An observational study of Cholestasis, run by Medical University of Vienna.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01164878, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2016.