Trial · NCT04217421
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Relevant parenchymatous brain injury on postoperative MRI | between birth and 1 month after cardiac surgery | The presence or absence of relevant (moderate/severe) parenchymatous (ischemic or hemorrhagic) brain injury on postoperative MRI will be assessed, using the T1/T2/DWI and SWI weighted images. |
| Primary | Rate of children that are considered 'too unstable for postoperative MRI' | between birth and 1 month after cardiac surgery | This decision is based on the circulatory and respiratory status of the child before the planned postoperative MRI, as included in local guidelines (not part of this protocol) of each participating center. |
| Primary | Incidence of mortality | between birth and 1 month after cardiac surgery | Defined as death until one month postoperatively. |
| Secondary | Brain injury severity score on pre- and postoperative MRI | between birth and 1 month after cardiac surgery | An MRI score, which includes diffusion-weighted imaging as well as assessment of the deep grey matter, white matter, and cerebellum \[Weeke L, et al. J Pediatr 2018\]. The score will be compared between groups (allopurinol vs placebo). |
| Secondary | Volume of hypoxic-ischemic brain injury on pre- and postoperative MRI | between birth and 1 month after cardiac surgery | To assess whether there are differences between groups (allopurinol vs placebo) in volume (mm3) of hypoxic-ischemic brain lesions using a fully automatic method for detection and quantification of ischemic lesions in diffusion-weighted MR images \[Murphy K, et al. Neuroimage Clin 2017\]. |
| Secondary | Global ventricular function (normal, mildly, moderately, severely, reduced) pre- and postoperatively | between birth and 1 month after cardiac surgery | |
| Secondary | Ventricular ejection fraction (%) pre- and postoperatively | between birth and 1 month after cardiac surgery | |
| Secondary | Brain function: Seizure activity on aEEG (presence or absence) postnatally and postoperatively | 24-36 hours after birth, 6 hours before surgery, 48-72 hours after surgery | |
| Secondary | Brain oxygenation: Regional cerebral oxygen saturation (%) postnatally and postoperatively | 24-36 hours after birth, 6 hours before surgery, 48-72 hours after surgery | |
| Secondary | General movements and motor optimality score | at 3 months | Video recordings will be analyzed following the global general movement categories (normal, poor repertoire, cramped-synchronized, or chaotic) and the motor optimality score \[Einspieler C, et al. Dev Med Child Neurol. 2016\]. A higher score expresses a more optimal performance. Scores will be compared between groups (allopurinol vs placebo). |
| Secondary | Neurodevelopment | at 24 months | To assess motor, cognitive, speech and language development using the Bayley Scales of Infant and Toddler Development - Third Edition - NL (Bayley-III-NL). An average Bayley-III-NL score is 100, one standard deviation (SD) above or below the mean concerns 15 points. Scores will be compared between groups (allopurinol vs placebo). |
| Secondary | Quality of Life (scores and subscores): TNO-AZL TAPQoL | at 24 months | The TNO-AZL Questionnaire for Preschool Children's Health-Related Quality of Life (TAPQoL) will be assessed to give insight in the quality of life of both children with CCHD and their parents. A higher score indicates a better quality of life. Scores will be compared between groups (allopurinol vs placebo). |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT04217421/registered