A Multi-center Trial to Determine if Curosurf® Reduces the Duration of Mechanical Ventilation in Very Preterm Infants
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.
Respiratory Distress Syndrome
Drug: BLES-group 2
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- 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 [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
- rate on ventilator ≤40 per minute and
- mean airway pressure ≤ 10 cm H20 and
- fi02 ≤ 30%
- 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. [ Time Frame: 36 weeks GA ] [ Designated as safety issue: Yes ]1. Extubation failure
- Curosurf-01 [ Time Frame: 36 weeks GA ] [ Designated as safety issue: Yes ]2. Duration of first intubation (in hours/days)
- Curosurf-01 [ Time Frame: 36 weeks GA ] [ Designated as safety issue: Yes ]3. Total duration of respiratory support (ventilator and nCPAP) and total number of days of oxygen requirement
- Curosurf-01 [ Time Frame: 36 weeks GA ] [ Designated as safety issue: Yes ]4. Number of doses of surfactant received
- Curosurf-01 [ Time Frame: 36 weeks GA ] [ Designated as safety issue: Yes ]5. Adverse events during or after administration of surfactant
- Curosurf-01 [ Time Frame: 36 Weeks GA ] [ Designated as safety issue: Yes ]6. Bronchopulmonary dysplasia, defined as oxygen or respiratory support requirement at 36 weeks corrected GA
- Curosurf-01 [ Time Frame: 36 weeks GA ] [ Designated as safety issue: Yes ]7. Mortality prior to discharge
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Experimental: Curosurf (Group 1)
Surfactant(Curosurf in this arm) is given for treatment of RDS after the diagnosis has been made by the Neonatologist. The treatment dose for Curosurf® is 2.5 ml/kg (200mg/kg) for the first dose and 1.25 ml/kg (100mg/kg) for repeat doses, given by endotracheal method. There is a maximum of 3 doses in the study.
Maximum of 3 doses are administered to infants diagnosed with RDS.
Active Comparator: BLES (Group 2)
Surfactant(BLES in this arm) is given for treatment of RDS after the diagnosis has been made by the Neonatologist. For BLES the recommended dose is 5 ml/kg. given by endotracheal method. There is a maximum of 3 doses in the study.
Drug: BLES-group 2
Maximum of 3 doses are administered to infants with RDS
Please refer to this study by its ClinicalTrials.gov identifier: NCT01709409
|Contact: Brigitte Lemyre, MD||6137378899 ext firstname.lastname@example.org|
|Contact: Chantal Horth||6137377600 ext email@example.com|
|The Ottawa Hospital||Recruiting|
|Ottawa, Ontario, Canada, K1H8L6|
|Contact: Chantal Horth 6137377600 ext 6041 firstname.lastname@example.org|
|Principal Investigator: Brigitte Lemyre, MD|
|Principal Investigator:||Brigitte Lemyre, MD||OHRI|