Phase 3
Completed N=88
A Multi-center Trial to Determine if Curosurf® Reduces the Duration of Mechanical Ventilation in Very Preterm Infants
Source: ClinicalTrials.gov NCT01709409 ↗Enrolled (actual)
88
Serious AEs
18.4%
Results posted
Oct 2017
Primary outcomePrimary: The Primary Objective of the Study is to Compare Between the Two Groups, the Number of Subjects Alive and Extubated at 48 Hours Post Surfactant Administration. Extubation — 21; 26 Participants
◆ Published Evidence
Emerging
19citations · ~2 / year
Poractant alfa versus bovine lipid extract surfactant for infants 24+0 to 31+6 weeks gestational age: A randomized controlled trial.
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.
Linked Publications
-
Poractant alfa versus bovine lipid extract surfactant for infants 24+0 to 31+6 weeks gestational age: A randomized controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Objective of the Study is to Compare Between the Two Groups, the Number of Subjects Alive and Extubated at 48 Hours Post Surfactant Administration. Extubation |
21; 26 | — |
| SECONDARY To Compare the Duration of Respiratory Support, Extubation Failure Rates, Need for Additional Surfactant Doses, Adverse Events (During and Following Administration), Survival and Pulmonary Morbidities During Hospital Admission Between the Two Groups. |
— | — |
| SECONDARY Curosurf-01 |
— | — |
Eligibility Criteria
Inclusion Criteria
- Infants born between 24+0 and 31+6 weeks gestational age, admitted to the study centers
- Infants with RDS requiring intubation and surfactant therapy within 48 hours after birth
Exclusion Criteria
- Any infant more than 48 hours of age
- Any infant with a pulmonary hemorrhage
- Any infant with life-threatening congenital anomaly or one that is considered non-viable
- Any infant on rescue high frequency ventilation
- Any infant known to require early intubation and ventilation for surgical treatment of a congenital anomaly
- Any infant with anomalies of the upper or lower airway or mandible precluding use of nCPAP
- Any infant born after prolonged premature rupture of membranes ( 28 days prior to delivery)
- A parent/LAR who is incapable of, or unwilling, to give consent
- Participation in another clinical trial of any placebo, drug, biological, or device conducted under the provisions of a protocol
- Any other reason as deemed significant by the Investigator
Data sourced from ClinicalTrials.gov (NCT01709409) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.