E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to severe cerebral palsy |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess whether magnesium sulphate given to women at imminent risk of preterm birth can prevent cerebral palsy. The results from this RCT will be added to a previous meta-analysis to obtain firm evidence for magnesium sulphate as a neuroprotector. |
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E.2.2 | Secondary objectives of the trial |
Secondary endpoints are: blindness, composite outcome of cerebral palsy and death, perinatal death, intraventricular hemorrhage, periventricular leukomalacia, Apgar score less than seven after five minutes, need for active resuscitation (assisted ventilation, compression etc.) at birth, neonatal convulsions, use of respiratory support (mechanical ventilation or continuous positive airway pressure or both, chronic lung disease (need for continuous supplemental oxygen at 28 days postnatal or 36 weeks’ postmenopausal age, infection, hypotension, retinopathy of prematurity, necrotizing enterocolitis, deafness, length of neonatal hospitalization, patent ductus arteriosus, use of antibiotics. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Women aged 18 years or older were eligible if they were pregnant with singletons or twins and were expected to give birth within 24 hours at gestational age 24+0 to 31+6 weeks. |
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E.4 | Principal exclusion criteria |
Major fetal anomalies, maternal contraindication to Mgso4, MgSO4 administrated for other reasons (preeclampsia), lack of ability ot read and speak Danish |
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E.5 End points |
E.5.1 | Primary end point(s) |
Moderate-severe cerebral palsy |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Secondary endpoints are: blindness, composite outcome of cerebral palsy and death, perinatal death, intraventricular hemorrhage, periventricular leukomalacia, Apgar score less than seven after five minutes, need for active resuscitation (assisted ventilation, compression etc.) at birth, neonatal convulsions, use of respiratory support (mechanical ventilation or continuous positive airway pressure or both, chronic lung disease (need for continuous supplemental oxygen at 28 days postnatal or 36 weeks’ postmenopausal age, infection, hypotension, retinopathy of prematurity, necrotizing enterocolitis, deafness, length of neonatal hospitalization, patent ductus arteriosus, use of antibiotics. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Minimum 18 moths of age: mortality, composite outcome of CP and mortality, blindness, retinopathy of prematurity, patent ductus arteriosus Apgar scores: after 1,5 and 10 minutes Moderate BPD: Need for continuous, supplemental oxygen at 28 days in addition to supplemental oxygen at ≤30% at 36 week postmenstrual age Severe BPD: Need for continuous, supplemental oxygen at 28 days in addition to supplemental oxygen at >30% at 36 week postmenstrual age Other outcomes: from birth to discharge after first neonatal admission |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 14 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The trial will be terminated when the last child is 18 months old and all possible children are assessed for primary and secondary outcomes. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 7 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |