Trial · NCT04217421
Cerebrum and Cardiac Protection With Allopurinol in Neonates With Critical Congenital Heart Disease Requiring Cardiac Surgery With Cardiopulmonary Bypass
NCT04217421, Phase 3, Recruiting, dr. M.J.N.L. Benders
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Cerebrum and Cardiac Protection With Allopurinol in Neonates With Critical Congenital Heart Disease Requiring Cardiac Surgery With Cardiopulmonary Bypass. Trials, record NCT04217421. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04217421
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cerebrum and Cardiac Protection With Allopurinol in Neonates With Critical Congenital Heart Disease Requiring Cardiac Surgery With Cardiopulmonary Bypass
- NCT number
- NCT04217421
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 236 participants, estimated
- Lead sponsor
- dr. M.J.N.L. Benders
- Conditions
- Congenital Heart Disease in Children, Neuroprotection
- Interventions
- Allopurinol, Mannitol
- First posted
- 2020-01-03
- Last updated
- 2024-05-16
- Other registries' IDs
- eudract:2017-004596-31
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04217421
GET https://conductscience.org/api/trials/v1/NCT04217421/registered