Brain injury termed “hypoxic-ischemic encephalopathy” (HIE) as a result of various events during labour and childbirth such as placental abruption, etc.), umbilical cord complications, uterine rupture
Conditions
Brief summary
Death versus severe neurodevelopmental impairment versus survival without severe neurodevelopmental impairment at the age of two years
Detailed description
Death or neurodevelopmental impairment (NDI) The primary endpoint will be reconstituted as dichotomised composite secondary endpoint (survival without NDI versus Death or languagecomposite- score < 85 or cognitive-composite-score <85 or cerebral palsy present)., Incidence of CP Incidence of CP will be analyzed by Cochrane-Mantel-Haenzel- X²-Test., GMFCS-score 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 (separate document not part of this protocol) will be analysed. GMFCS-score consists of six categories., Motor-Composite-Score (Bayley III), Motor-Composite-Score dichotomised (Bayley III) The motor-composite-score will be dichotomised at the cut-off <85 versus ≥85, Cognitive-Composite-Score (cognitive subscale, Bayley III), Cognitive-Composite-Score dichotomised (cognitive subscale, Bayley III) The cognitive-composite-score will be dichotomised at the cut-off <85 versus ≥85, Language-Composite-Score (language subscale, Bayley III), Language-Composite-Score dichotomised (language subscale, Bayley III) The language-composite-score will be dichotomised at the cut-off <85 versus ≥85, Single Components of primary endpoint - Graph Single components and observed combinations of the primary endpoint (healthy, death, CP, language-composite-score <85, cognitivecomposite- score <85) will be displayed graphically stratified for the two treatment groups.
Interventions
Sponsors
Universitaetsklinikum Tuebingen AöR
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Death versus severe neurodevelopmental impairment versus survival without severe neurodevelopmental impairment at the age of two years | — |
Secondary
| Measure | Time frame |
|---|---|
| Death or neurodevelopmental impairment (NDI) The primary endpoint will be reconstituted as dichotomised composite secondary endpoint (survival without NDI versus Death or languagecomposite- score < 85 or cognitive-composite-score <85 or cerebral palsy present)., Incidence of CP Incidence of CP will be analyzed by Cochrane-Mantel-Haenzel- X²-Test., GMFCS-score 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 (separate document not part of this protocol) will be analysed. GMFCS-score consists of six categories., Motor-Composite-Score (Bayley III), Motor-Composite-Score dichotomised (Bayley III) The motor-composite-score will be dichotomised at the cut-off <85 versus ≥85, Cognitive-Composite-Score (cognitive subscale, Bayley III), Cognitive-Composite-Score dichotomised (cognitive subscale, Bayley III) The cognitive-composite-score will be dichotomis | — |
Countries
Austria, Belgium, Estonia, Finland, Germany, Italy, Netherlands, Norway, Spain
Outcome results
None listed