Neonatal Respiratory Distress Syndrome
Conditions
Keywords
RDS
Brief summary
The present study will mainly aim at investigating the safety, tolerability and efficacy of different escalating single doses administration of nebulised Curosurf®, in preterm neonates with RDS (Respiratory Distress Syndrome) during nCPAP.
Detailed description
The study will be conducted in spontaneously breathing preterm neonates with mild to moderate RDS and will consist of two parts: Part I, with the objective to assess the safety and tolerability of single ascending doses of nebulised Curosurf® ; Part II, with the objective to compare the efficacy of nebulised Curosurf®, administered at two selected doses from part I, during nCPAP, versus nCPAP alone in terms of incidence of respiratory failure in the first 72 hours of life.
Interventions
DRUGnCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part I)
Single ascending doses of Curosurf® administered through nebulisation to neonates receiving nCPAP (Part I)
DRUGnCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part II)
Two doses of Curosurf® administered through nebulisation to neonates receiving nCPAP (Part II)
OTHERnCPAP (nasal Continuous Positive Airway Pressure) alone (Part I)
Nasal continuous positive airway pressure alone
OTHERnCPAP (nasal Continuous Positive Airway Pressure) alone (Part II)
nasal continuous positive airway pressure alone
Sponsors
Chiesi Farmaceutici S.p.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Part I is an ascending dose scheme of IMP versus nCPAP alone. Part II is a parallel group with 2 doses of IMP versus nCPAP alone. In part II, one additional dose may be administered between 3 and 12 hours after the start of the first dose.
Eligibility
Sex/Gender
ALL
Age
28 Weeks to 32 Weeks
Healthy volunteers
No
Inclusion criteria
1. Written informed consent obtained by parents/legal representative (according to local regulation) prior to or after birth 2. Inborn neonates from 28+0 to 32+6 weeks of gestational age (GA), spontaneously breathing and stabilised on nCPAP 3. Clinical course consistent with RDS. 4. Receiving CPAP pressure 5-8 centimeter of water (cm H2O) and fraction of inspired oxygen (FiO2) between 0.25 and 0.40 to maintain saturation of peripheral oxygen (SpO2) between 88% and 95% for at least 30 minutes. Randomization should occur between 60 minutes and 12 hours after birth.
Exclusion criteria
1. Early need for endotracheal intubation for cardiopulmonary resuscitation in delivery room or within 1 hour from birth because of severe RDS 2. Respiratory Distress not secondary to surfactant deficiency 3. Use of surfactant prior to study entry and need for endotracheal administration of any other treatment. 4. Major congenital anomalies. 5. Evidence of severe birth asphyxia 6. Mothers with prolonged rupture of the membranes 7. Presence of air leaks. 8. Presence of IVH (intraventricular hemorrhage ) ≥ III. 9. Hypotension or evidence of hemodynamic instability. 10. Any condition that, in the opinion of the Investigator, would place the neonate at undue risk. 11. Participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of neonates with respiratory failure | in the first 72 hours of life | Respiratory failure defined as: need for endotracheal surfactant administration and/or mechanical ventilation |
| Adverse Events | discharge or 36 weeks post menstrual age (PMA), whichever comes first | Any untoward medical occurrence in a clinical trial neonate administered a medicinal product and which does not necessarily have a casual relationship with the treatment |
| Adverse Drug Reactions | discharge or 36 weeks post menstrual age (PMA), whichever comes first | Any untoward and unintended responses to an investigational product related to any dose administered |
Countries
Italy
Outcome results
None listed