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Onderzoek naar de bloedvoorziening van de hersenen bij kinderen met een aangeboren hartafwijking


- candidate number22223
- NTR NumberNTR5233
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-mei-2015
- Secondary IDsNL45567.042.14 University Medical Center Groningen
- Public TitleOnderzoek naar de bloedvoorziening van de hersenen bij kinderen met een aangeboren hartafwijking
- Scientific TitleLate neonatal neurological outcome in infants with prenatally diagnosed duct dependent CHD and its relation with fetal and neonatal cerebral perfusion
- ACRONYMPANCAKE
- hypothesisThe objective of the study is to gain more insight into brain damage in infants with congenital heart disease. We hypothesize that infants with congenital heart disease are at risk of developing brain damage during early life or even before birth.
- Healt Condition(s) or Problem(s) studiedCongenital heart defects, Neonates, Neurodevelopmental outcome, Suprastructure complications
- Inclusion criteriaA cardiac anomaly on ultrasound before birth Admission to the NICU after birth
- Exclusion criteriaPremature birth before a gestational age of 36 weeks
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 30-apr-2014
- planned closingdate1-apr-2016
- Target number of participants25
- Interventionsnone
- Primary outcomeGeneral movements (GMs) according to Prechtl's method
- Secondary outcomeMultisite near-infrared spectroscopy (NIRS) Antenatal doppler flow profiles
- TimepointsFrom diagnosis before birth to an age of three months.
GMs: age of seven days and age of three months
NIRS: day 1-7 after birth, during and after corrective surgery
Antenatal Doppler flow profiles: every 4 weeks after diagnosis
- Trial web sitenot applicable
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES E.M.W. Kooi
- CONTACT for SCIENTIFIC QUERIES E.M.W. Kooi
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
None
- Publications
- Brief summaryInfants with congenital heart disease are at risk of developing brain damage. This study is designed to gain more insight into the timing of brain damage via non-invasive clinical tools such as antenatal Doppler flow profiles, multisite near-infrared spectroscopy and general movements according to Prechtl's method.
- Main changes (audit trail)
- RECORD24-mei-2015 - 11-aug-2015


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