A Double Blind, Randomized, Controlled Study to Evaluate CHF 5633 (Synthetic Surfactant) and Poractant Alfa in Neonates With Respiratory Distress Syndrome (RDS) (POC)
Condition: Respiratory Distress Syndrome, Newborn
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Syndrome
Intervention: CHF5633; Poractant alfa
Intervention description: Rescue treatment (if needed); Rescue treatment (if needed)
Intervention MeSH terms: Poractant alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 123.0
Sex: All
Minimum age: 1 Hour
Maximum age: 24 Hours
Healthy volunteers: No
Keywords: neonates, pulmonary surfactant

Summary:

      A multicenter, double blind, randomized, single dose, active-controlled study to investigate
      the efficacy and safety of synthetic surfactant (CHF 5633) in comparison to porcine
      surfactant (Poractant alfa, Curosurf ®) in the treatment of preterm neonates with respiratory
      distress syndrome. Main objectives of this study are to investigate the short term efficacy
      profile of CHF 5633 vs. porcine surfactant (Poractant Alfa, Curosurf®) in terms of reduced
      oxygen requirement and ventilatory support and to evaluate the mid-term efficacy profile in
      terms of reduced incidence of bronchopulmonary dysplasia (BPD) and mortality/BPD rate at 36
      weeks post menstrual age (PMA), mortality rate at 28 days and 36 weeks PMA, RDS-associated
      mortality through 14 days of age and other major co-morbidities of prematurity.

      Inclusion criteria are: Written parental informed consent, inborn preterm neonates of either
      sex with a gestational age of 24+0 weeks up to 29+6 weeks, clinical course consistent with
      RDS, requirement of endotracheal surfactant administration within 24 hours from birth,
      fraction of inspired oxygen (FiO2) ≥0.30 for babies 24+0 to 26+6 weeks and FiO2 ≥0.35 for
      babies 27+0 to 29+6 weeks to maintain arterial oxygen saturation by pulse oximetry (SpO2)
      between 88-95%.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written informed consent obtained by parents/legal representative (according to local
             regulation) prior to any study-related procedures

          2. Inborn preterm neonates of either sex with a gestational age of 24+0 weeks up to 29+6
             weeks

          3. Clinical course consistent with RDS

          4. Requirement of endotracheal surfactant administration within 24 hours from birth

          5. Fraction of inspired oxygen (FiO2) ≥0.30 for babies 24+0 to 26+6 weeks and FiO2 ≥0.35
             for babies 27+0 to 29+6 weeks to maintain SpO2 between 88-95%

        Exclusion Criteria:

          1. Use of surfactant prior to study entry and need for intratracheal administration of
             any other treatment (e.g. nitric oxide)

          2. Known genetic or chromosomal disorders, major congenital anomalies (cardiac
             malformations, myelomeningocele etc)

          3. Maternal drug abuse (heroin, methadone, methamphetamine, or cocaine) or significant
             alcohol consumption during pregnancy

          4. Mothers with prolonged rupture of the membranes (>21 days duration)

          5. Strong suspicion of congenital pneumonia/infection, sepsis

          6. Presence of air leaks prior to study entry

          7. Evidence of severe birth asphyxia

          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 placebo, drug or biological substance
             conducted under the provisions of a protocol.