Phase 3 N=88 Randomized Quadruple-blind Treatment

A Multi-center Trial to Determine if Curosurf® Reduces the Duration of Mechanical Ventilation in Very Preterm Infants

Respiratory Distress Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT01709409 ↗

Enrolled (actual)

Serious AEs

18.4%

Results posted

Oct 2017

Primary outcome: 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 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Curosurf-Group1 (Drug); BLES-group 2 (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Ottawa Hospital Research Institute
Primary completion: Aug 2016

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	—	—
SECONDARY Curosurf-01	—	—
SECONDARY Curosurf-01	—	—
SECONDARY Curosurf-01	—	—
SECONDARY Curosurf-01	—	—
SECONDARY Curosurf-01	—	—

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01709409). 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.