E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The study investigates reoxygenation injury in cyanotic paediatric patients undergoing on-pump cardiac surgery. The types of heart condition being investigated result in chronic low blood oxygen saturation, causing cyanosis. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10010395 |
E.1.2 | Term | Congenital cardiac malpositions and transpositions |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10010397 |
E.1.2 | Term | Congenital cardiac structural defects NEC |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10010396 |
E.1.2 | Term | Congenital cardiac septal defect NOS |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10062326 |
E.1.2 | Term | Congenital cardiac septal defect |
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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 |
The main objective of the trial is to assess the clinical health effects of controlling reoxygenation during cariopulmonary bypass in cyanotic paediatric patients undergoing cardiac surgery.
The primary measure of this is 'clinical outcome', defined in particular by duration of inotropic support, intubation time, time in ICU and length of postoperative stay. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to investigate the effects of controlling reoxygenation on the following factors:
1 - In-hospital mortality and morbidity 2 - Developmental neurocognitive measures 3 - Brain injury 4 - Renal function 5 - Gene expression profiles in myocardial DNA 6 - Myocardial cell contractility 7 - School entry test results (with parental permission) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Cyanotic children (SaO2 ≤ 92%) undergoing operations to repair a heart defect 2. Children aged ≥ 1 month of age |
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E.4 | Principal exclusion criteria |
1. Preoperative diagnosis of Down’s syndrome or other developmental disorders (for the assessment of developmental outcomes) 2. Emergency operations 3. Neonatal patients (<1 month old). 4. Patients undergoing SWITCH procedures
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E.5 End points |
E.5.1 | Primary end point(s) |
Clinical outcome, in particular duration of inotropic support, intubation time, ICU and postoperative stay is the primary outcome. |
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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 | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
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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Last Bayley assessment of the last patient (12months after randomisation) |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |