Neonatal Respiratory Distress Syndrome MedDRA version: 8.1 Level: LLT Classification code 10028974 Term: Neonatal respiratory distress syndrome
Conditions
Interventions
Trade Name: Curosurf
Product Name: Curosurf
Pharmaceutical Form: Endotracheopulmonary instillation, suspension
INN or Proposed INN: Poractant Alfa 1534 CHF
CAS Number: 129069-19-8
Other descriptive n
Sponsors
Chiesi Farmaceutici S p A
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: The secondary objectives are to evaluate the safety and overall clinical outcome of infants randomized into the study until 36 weeks post menstrual age.;Primary end point(s): The primary endpoint is the incidence of the need for MV (mechanical ventilation) within the first 5 days of life. | — |
Countries
Czech Republic, France, Italy, Portugal
Outcome results
None listed