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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
88
Maximum of 3 doses are administered to infants diagnosed with RDS.
Maximum of 3 doses are administered to infants with RDS
The Ottawa Hospital
Ottawa, Ontario, Canada
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
1. rate on ventilator ≤40 per minute and 2. mean airway pressure ≤ 10 cm H20 and 3. fi02 ≤ 30%
Time frame: 48 hours
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.
1\. Extubation failure
Time frame: 36 weeks GA
Curosurf-01
2\. Duration of first intubation (in hours/days)
Time frame: 36 weeks GA
Curosurf-01
3\. Total duration of respiratory support (ventilator and nCPAP) and total number of days of oxygen requirement
Time frame: 36 weeks GA
Curosurf-01
4\. Number of doses of surfactant received
Time frame: 36 weeks GA
Curosurf-01
5\. Adverse events during or after administration of surfactant
Time frame: 36 weeks GA
Curosurf-01
6\. Bronchopulmonary dysplasia, defined as oxygen or respiratory support requirement at 36 weeks corrected GA
Time frame: 36 Weeks GA
Curosurf-01
7\. Mortality prior to discharge
Time frame: 36 weeks GA
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