E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The medical condition for this application is the Respiratory Distress Syndrome (RDS). RDS, also known as hyaline membrane disease, is characterized by lung immaturity and surfactant deficiency and is the most common respiratory disorder in premature infants. The first clinical manifestations of RDS at birth are grunting respiration, subcostal and intercostal retractions, cyanosis and nasal flaring.
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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 |
The primary objective is to evaluate the safety of aerosolized Curosurf delivered via nasal continuous positive airway pressure (NCPAP) in infants with RDS. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to evaluate the efficacy of aerosolized Curosurf delivered via NCPAP in infants with RDS. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Patients who meet all of the following criteria are eligible to participate in the study:
1.RDS by clinical and radiographic criteria 2.Birth weight between and including 750 to 1000 g if gestional age (GA) ≥ 27 weeks, and between 1001 to 2500 g (no restrictions on GA) 3.Post-natal age of 2 to 4h 4.On NCPAP with FiO2 of 0.3-0.35 to maintain SaO2 87-93% for ≥ 30 min preceding randomization 5.Arterial line in place 6.At least one ABG obtained while on NCPAP with FiO2 of 0.3-0.35 to maintain SaO2 87-93% during the hour prior to randomization 7.Written informed consent obtained from parent or legal guardian prior to enrollment
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E.4 | Principal exclusion criteria |
Patients who meet any of the following criteria are not eligible to participate in the study:
1.Rupture of membranes > 6 days prior to delivery 2.Prior surfactant treatment 3.Any post-natal ABG with pH<7.20 4.Any ABG obtained ≤1h prior to randomization with pH<7.23 5.Pneumothorax, including pneumonthorax which has been successfully evacuated 6.Apgar score ≤ 3 at 5min post-natal age 7.Major congenital anomalies (e.g. CHD, myelomeningocele) 8.Congenital heart disease (does not include patent ductus arteriosus, patent foramen ovale or small ventricular defect) 9.Requiring >10 µg/kg/min dopamine to maintain acceptable blood pressure during the hour prior to randomization 10.Other medical problem that would potentially interfere with the conduct of the study or confound study endpoints 11.Previously received or are planned to receive any other experimental treatment during the study period
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoints of the trial are: - Clinically significant changes in vital signs - Incidence of treatment related adverse events and serious adverse events - Change in fraction of inspired oxygen (FiO2) - Need for Instilled surfactant
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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 | Yes |
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 | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 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 | 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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
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 | 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 | Information not present in EudraCT |
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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Sponsor reserves the right to terminate the study at a particlular site or in its entirety at any time. Reasons for terminating the study may include but is not limited to the following: 1.The incidence or severity of adverse events in this or other studies indicates a potential health hazard to patient 2.Patient enrollment is unsatisfactory 3.Data recording is inaccurate or incomplete 4.Administrative reasons
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 12 |