A Study in Preterm Neonates With RDS to Compare CUROSURF® Administration Through LISA and Conventional Administration

• Status: Recruiting
• Trial end date: 2025-09-30
• Target enrollment: 0
• Participant gender: All

Summary

This study will compare the administration of porcine surfactant (poractant alfa, Curosurf®) through a less invasive method (LISA) using a thin catheter, CHF 6440 (LISACATH®), during non-invasive ventilation (CPAP, NIPPV, BiPAP) with an approved conventional surfactant administration during invasive ventilation followed by rapid extubation in terms of short term and mid-term safety and efficacy in spontaneously breathing preterm neonates with clinical signs of respiratory distress syndrome (RDS).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.
• Collaborator: Quintiles, Inc.
• Treatments: Poractant alfa

Criteria

Inclusion Criteria:

1. Written informed consent obtained by parents/legal representative (according to local regulation) prior to or after birth

2. Preterm neonates of either sex aged ≥30 minutes and <24 hours, spontaneously breathing and stabilized on non-invasive ventilation (NIV).

3. Gestational age of 25+0 weeks up to 28+6 completed weeks, except for the first 15 enrolled neonates in which the gestational age will be restricted to 27+0 weeks up to 28+6 weeks.

4. Clinical course consistent with RDS.

5. Fraction of inspired oxygen (FiO2) ≥0.30 to maintain SpO2 between 88-95%.

Exclusion Criteria:

1. Need for immediate endotracheal intubation for cardiopulmonary resuscitation or insufficient respiratory drive

2. Use of nasal high frequency oscillatory ventilation (nHFOV) prior to study entry

3. Use of surfactant prior to study entry and need for intratracheal administration of any other treatment (e.g. nitric oxide)

4. Known genetic or chromosomal disorders, major congenital anomalies (congenital heart diseases, myelomeningocele etc)

5. Mothers with prolonged rupture of the membranes (> 21 days duration)

6. Presence of air leaks if identified and known prior to study entry

7. Evidence of severe birth asphyxia (e.g. continued need for resuscitation at 10 minutes after birth, altered neurological state, or neonatal encephalopathy)

8. Neonatal seizures prior to study entry

9. Any condition that, in the opinion of the Investigator, would place the neonate at undue risk

10. Participation in another clinical trial of any medicinal product, placebo, experimental medical device, or biological substance conducted under the provisions of a protocol on the same therapeutic target.