Trial · NCT03162653
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| 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. |
| Secondary | Language-Composite-Score dichotomised (language subscale, Bayley III) | at 24 months | The language-composite-score will be dichotomised at the cut-off \<85 versus ≥85 and analysed by Cochrane-Mantel-Haenszel- X²-Test |
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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