Clinical trial NCT01709409: A Multi-center Trial to Determine if Curosurf® Reduces the Duration of Mechanical Ventilation in Very Preterm Infants
Official title: A Randomized, Controlled, Partially Double-blinded, Phase 3, Multi-center Trial to Determine if Curosurf® Reduces the Duration of Mechanical Ventilation in Infants 24+0 to 31+6 Weeks Gestational Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Distress Syndrome
Keywords: Prematurity
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2012-10-18
Enrollment: 88
Sex: ALL
Minimum age (years): 24
Maximum age (years): 31
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: 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
timeFrame: 48 hours
Secondary outcomes:
measure: 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.
timeFrame: 36 weeks GA
measure: Curosurf-01
timeFrame: 36 weeks GA
measure: Curosurf-01
timeFrame: 36 weeks GA
measure: Curosurf-01
timeFrame: 36 weeks GA
measure: Curosurf-01
timeFrame: 36 weeks GA
measure: Curosurf-01
timeFrame: 36 Weeks GA
measure: Curosurf-01
timeFrame: 36 weeks GA
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: OHRI
name: Brigitte Lemyre, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lemyre B, Fusch C, Schmolzer GM, Rouvinez Bouali N, Reddy D, Barrowman N, Huneault-Purney N, Lacaze-Masmonteil T. Poractant alfa versus bovine lipid extract surfactant for infants 24+0 to 31+6 weeks gestational age: A randomized controlled trial. PLoS One. 2017 May 4;12(5):e0175922. doi: 10.1371/journal.pone.0175922. eCollection 2017.