A Multi-center Trial to Determine if Curosurf® Reduces the Duration of Mechanical Ventilation in Very Preterm Infants
Condition: Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
Intervention: Curosurf-Group1; BLES-group 2
Intervention description: Maximum of 3 doses are administered to infants diagnosed with RDS.; Maximum of 3 doses are administered to infants with RDS
Intervention MeSH terms: Poractant alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 88.0
Sex: All
Minimum age: 24 Weeks
Maximum age: 31 Weeks
Healthy volunteers: No
Keywords: Prematurity

Summary:

      The purpose of this study is to see if a medication called Curosurf can reduce the length of
      time that small premature babies with Respiratory Distress Syndrome (immature lungs) or RDS,
      stay on the ventilator, as compared to the standard medication called BLES. Curosurf is a
      medication that is already used in other countries around the world but not yet in Canada.

      Babies born under 32 weeks of gestation frequently need respiratory support after birth,
      including being placed on a breathing machine or respirator. The most common reason is
      Respiratory Distress Syndrome (RDS) whereby immature lungs don't produce enough surfactant, a
      soapy like substance that helps the air sacs open and close. Our current standard treatment
      is a surfactant called BLES. Curosurf contains more active ingredient per volume therefore
      the amount is smaller. The investigators hypothesize that babies who receive Curosurf will be
      able to be removed from the ventilator sooner.

      Babies in this study will have a 50/50 chance of receiving either Curosurf or BLES and the
      investigators will monitor their progress during their Neonatal Intensive Care Unit
      admission.

      The study is taking place in Canada. The goal is to enroll 88 babies. There are no extra
      tests (blood tests or X-Rays) or return visits to the hospital for the purposes of this
      study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Infants born between 24+0 and 31+6 weeks gestational age, admitted to the study
             centers

          2. Infants with RDS requiring intubation and surfactant therapy within 48 hours after
             birth

        Exclusion Criteria:

          1. Any infant more than 48 hours of age

          2. Any infant with a pulmonary hemorrhage

          3. Any infant with life-threatening congenital anomaly or one that is considered
             non-viable

          4. Any infant on rescue high frequency ventilation

          5. Any infant known to require early intubation and ventilation for surgical treatment of
             a congenital anomaly

          6. Any infant with anomalies of the upper or lower airway or mandible precluding use of
             nCPAP

          7. Any infant born after prolonged premature rupture of membranes (<22 weeks GA or >28
             days prior to delivery)

          8. A parent/LAR who is incapable of, or unwilling, to give consent

          9. Participation in another clinical trial of any placebo, drug, biological, or device
             conducted under the provisions of a protocol

         10. Any other reason as deemed significant by the Investigator