E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Neonatal Respiratory Distress Syndrome |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028974 |
E.1.2 | Term | Neonatal respiratory distress syndrome |
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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 primary objective is a comparative evaluation of the two methods of post-delivery stabilization and subsequent early respiratory care to reduce the need for mechanical ventilation (MV) and related secondary complications, such as BPD (Bronchopulmonary dysplasia), in premature babies at high risk of RDS (Respiratory Distress Syndrome):
1. Early stabilization on nCPAP (nasal continuous positive airway pressure). 2. Intubation, prophylactic surfactant (Curosurf) administration shortly after delivery, and rapid extubation to nCPAP.
The data obtained from this comparison will be applied to test the hypothesis that preterm neonates at risk of RDS who are treated with prophylactic surfactant + nCPAP show less need for MV when compared to infants who receive nCPAP alone. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to evaluate the safety and overall clinical outcome of infants randomized into the study until 36 weeks post menstrual age. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Preterm neonates will be randomized into the study via IVRS if the following inclusion criteria are met:
1. Preterm neonates with a GA (Gestational Age) of 25(+0) - 28(+6) completed weeks (see appendix II).
2. Inborn neonates.
3. In case of twins, both neonates will be included in the same treatment arm (for details see Section 6.2 "Treatment Assignment" of the Protocol).
4. Parental written informed consent for participation in the study obtained on admission to hospital or prior to delivery.
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E.4 | Principal exclusion criteria |
Preterm neonates will not be randomized into the study if at least one of the following criteria is met:
1. Evidence of severe birth asphyxia or an APGAR score below 3 at 5 minutes of age.
2. Need for endotracheal intubation for cardiopulmonary resuscitation or insufficient respiratory drive.
3. Known genetic or chromosomal disorders.
4. Delivered to mothers with ruptured membranes of more than 3 weeks duration.
5. Potentially life-threatening conditions unrelated to immaturity.
6. Participation in another clinical trial of any placebo , drug, biological, or device conducted under the provisions of a protocol. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the incidence of the need for MV (mechanical ventilation) within the first 5 days of life. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Nasal Continuous Positive Airway pressure |
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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 | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 32 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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 patient out is projected for January 2008 |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |