search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Neurodevelopmental outcome and quality of life in infants with (congenital) liver disease


- candidate number25454
- NTR NumberNTR6207
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-okt-2016
- Secondary IDs201600843 UMCG Research Register
- Public TitleNeurodevelopmental outcome and quality of life in infants with (congenital) liver disease
- Scientific TitleCongenital Liver diseases and Neurological Outcome
- ACRONYMCOLINO
- hypothesisInfants with congenital liver disease and/or who underwent a liver transplantation < 5 year will have more neurodevelopmental problems and an impaired quality of life at school age when compared to healthy peers.
- Healt Condition(s) or Problem(s) studiedCongenital liver disease, Neurodevelopmental outcome
- Inclusion criteria- All infants with congenital liver disease in the Netherlands.
- All infants who had a liver transplantation < 5 year in the Netherlands.
- Exclusion criteria- Deceased infants.
-Neurodevelopmental sequelae due to other problems (e.g. syndromal)
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-sep-2016
- planned closingdate1-sep-2020
- Target number of participants75
- Interventions-
- Primary outcomeNeurodevelopmenatal outcome
Quality of Life
- Secondary outcomeRisk factors for impaired neurodevelopmental outcome / Quality of life
- TimepointsSchool age (6-12 years of age)
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD/PhD J.L.M. Bruggink
- CONTACT for SCIENTIFIC QUERIESMD/PhD J.L.M. Bruggink
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
MLDS
- Publications
- Brief summaryBackground Congenital liver disorders often present shortly after birth, and in a large number of infants this leads to a liver transplantation before the age of 18 years. Previous studies showed that children who underwent a liver transplantation often have neuropsychological developmental problems. Recently we performed a pilot study in which the neuropsychological development at school age (6-12 years) in children with biliary atresia was examined. This analysis showed that these children achieve poorer results in motor, cognitive and behavioral tests compared to their healthy peers. The reason for these developmental problems is still unclear.

Methods All children born in the Netherlands and Denmark with congenital liver disease will be asked to undergo validated neuropsychological tests, at different ages (3 months post-term, 18 months and between 6 and 12 years old). The results of these tests are correlated with different clinical parameters and risk factors to identify those children at high-risk for developmental problems.

Expected results We expect to give an overview of the neuropsychological development of children born with congenital liver disease at school age. And furthermore to identify risk factors, in this population, for impaired neuropsychological development. Early identification of those infants at high risk for developmental problems may give us the ability to provide extra guidance or treatment in order to promote their quality of life and social participation.
- Main changes (audit trail)
- RECORD25-okt-2016 - 5-mrt-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl