A Study in Preterm Neonates With Respiratory Distress Syndrome (RDS) Comparing CUROSURF® Administration Through Less Invasive Surfactant Administration (LISA) and Conventional Administration
Condition: Respiratory Distress Syndrome (RDS)
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Syndrome
Intervention: LISA combination product (Curosurf+catheter CHF6440); Curosurf through conventional administration (endotracheal tube)
Intervention description: Curosurf administration through brief insertion of a thin catheter into the trachea; Curosurf through conventional administration (endotracheal tube), followed by rapid extubation
Intervention MeSH terms: Poractant alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 30 Minutes
Maximum age: 24 Hours
Healthy volunteers: No
Keywords: Less Invasive Surfactant administration; LISPAP; Neonates; Newborns; Respiratory Distress Syndrome (RDS); CUROSURF®

Summary:

      This study compared 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 who have
      clinical signs of respiratory distress syndrome (RDS).
    

Eligibility 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 preductal oxygen saturation
             (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.