Trial · NCT03162653
Effect of Allopurinol for Hypoxic-ischemic Brain Injury on Neurocognitive Outcome
NCT03162653, Phase 3, Unknown, University Hospital Tuebingen
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Effect of Allopurinol for Hypoxic-ischemic Brain Injury on Neurocognitive Outcome. Trials, record NCT03162653. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03162653
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Allopurinol for Hypoxic-ischemic Brain Injury on Neurocognitive Outcome
- NCT number
- NCT03162653
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 760 participants, estimated
- Lead sponsor
- University Hospital Tuebingen
- Conditions
- Encephalopathy, Hypoxic-Ischemic, Infant, Newborn, Diseases
- Interventions
- Allopurinol, Mannitol
- First posted
- 2017-05-22
- Last updated
- 2023-07-11
- Other registries' IDs
- eudract:2016-000222-19
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | death versus severe neurodevelopmental impairment versus survival without severe neurodevelopmental impairment | at the age of 24 months | Where severe neurodevelopmental impairment is defined as any of the following: cognitive or language delay defined as a cognitive-composite-score or a language-composite-score on the Bayley Scales of Infant and Toddler Development (3rd edition) \< 85 and/or cerebral palsy (CP) according to SCPE criteria \[SCPE Dev Med Child Neurol 2000\]. In case of missing Bayley III test results, Bayley II or other developmental test results or PARCA-R parent questionnaire results may substitute for the Bayley III test result in a predefined hierarchical order. Primary endpoint with three mutually exclusive responses (healthy, death, composite outcome for impairment) will be analyzed in the two treatment groups by a generalized logits model according to Bishop, Fienberg, Holland 1975 with SAS 9.4 procedure proc catmod. |
| Secondary | Death or neurodevelopmental impairment (NDI) | at 24months | The primary endpoint will be reconstituted as dichotomised composite secondary endpoint (survival without NDI versus Death or language-composite-score \< 85 or cognitive-composite score \<85 or cerebral palsy present). In case of missing Bayley III test results, Bayley II or other developmental test results or PARCA-R parent questionnaire results may substitute for the Bayley III test result in a predefined hierarchical order. This will be analyzed by Cochrane-Mantel-Haenszel- X²-Test. |
| Secondary | Incidence of Death | at 24 months | Incidence of death will be analyzed by Cochrane-Mantel-Haenszel- X²-Test. |
| Secondary | Incidence of CP | at 24 months | Incidence of CP according to SCPE criteria \[SCPE Dev Med Child Neurol 2000\] will be analyzed by Cochrane-Mantel-Haenszel- X²-Test. |
| Secondary | GMFCS-score | at 24 months | GMFCS-Score for quantification of the effects of cerebral palsy and other motor impairments (adapted from Palisano et al. \[Palisano Med Child Neurol 1997\]) using the ALBINO-GMFCS-score sheet will be analysed. GMFCS-score consists of six categories. Analysis will be done by using Wilcoxon-Mann-Whitney test. |
| Secondary | Motor-Composite-Score (Bayley III) | at 24 months | The numerical data of the motor-composite-score will be analysed using Wilcoxon-Mann-Whitney test. The use of this test accounts for the fact that data will be cut due to lack of sensitivity below 50 points. |
| Secondary | Motor-Composite-Score dichotomised (Bayley III) | at 24 months | The motor-composite-score will be dichotomised at the cut-off \<85 versus ≥85 and analysed by Cochrane-Mantel-Haenszel- X²-Test. |
| Secondary | Cognitive-Composite-Score (cognitive subscale, Bayley III) | at 24 months | The numerical data of the cognitive-composite-score will be analysed using Wilcoxon-Mann-Whitney test. The use of this test accounts for the fact that data will be cut due to lack of sensitivity below 50 points. |
| Secondary | Cognitive-Composite-Score dichotomised (cognitive subscale, Bayley III) | at 24 months | The cognitive-composite-score will be dichotomised at the cut-off \<85 versus ≥85 and analysed by Cochrane-Mantel-Haenszel- X²-Test. |
| Secondary | Language-Composite-Score (language subscale, Bayley III) | at 24 months | The raw numerical data of the language-composite-score will be analysed using Wilcoxon Mann-Whitney test. The use of this test accounts for the fact that data will be cut due to lack of sensitivity below 50 points. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 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.
Papers4
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/NCT03162653
GET https://conductscience.org/api/trials/v1/NCT03162653/registered