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

• ClinicalTrials.gov Identifier: NCT01709409
• Recruitment Status: Completed
• First Posted: October 18, 2012
• Results First Posted: October 25, 2017
• Last Update Posted: October 25, 2017
• Sponsor: Ottawa Hospital Research Institute
• Information provided by (Responsible Party): Ottawa Hospital Research Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Respiratory Distress Syndrome	Drug: Curosurf-Group1; Drug: BLES-group 2	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: March 2013
• Actual Primary Completion Date: August 2016
• Actual Study Completion Date: August 2016

Arms and Interventions

Arm	Intervention/treatment
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.	Drug: Curosurf-Group1; 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

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   1. rate on ventilator ≤40 per minute and
   2. mean airway pressure ≤ 10 cm H20 and
   3. fi02 ≤ 30%

Secondary Outcome Measures :

1. 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 ]
   1. Extubation failure
2. Curosurf-01 [ Time Frame: 36 weeks GA ]
   2. Duration of first intubation (in hours/days)
3. Curosurf-01 [ Time Frame: 36 weeks GA ]
   3. Total duration of respiratory support (ventilator and nCPAP) and total number of days of oxygen requirement
4. Curosurf-01 [ Time Frame: 36 weeks GA ]
   4. Number of doses of surfactant received
5. Curosurf-01 [ Time Frame: 36 weeks GA ]
   5. Adverse events during or after administration of surfactant
6. Curosurf-01 [ Time Frame: 36 Weeks GA ]
   6. Bronchopulmonary dysplasia, defined as oxygen or respiratory support requirement at 36 weeks corrected GA
7. Curosurf-01 [ Time Frame: 36 weeks GA ]
   7. Mortality prior to discharge

Eligibility Criteria

• Ages Eligible for Study: 24 Weeks to 31 Weeks (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Canada, Ontario

The Ottawa Hospital

Ottawa, Ontario, Canada, K1H8L6

Sponsors and Collaborators

Ottawa Hospital Research Institute

Investigators

• Principal Investigator: Brigitte Lemyre, MD; OHRI

More Information

Additional Information:

Product information 

Publications of Results:

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.

• Responsible Party: Ottawa Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT01709409
• Other Study ID Numbers: Curosurf-01
• First Posted: October 18, 2012
• Results First Posted: October 25, 2017
• Last Update Posted: October 25, 2017
• Last Verified: June 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by Ottawa Hospital Research Institute:

Prematurity

Additional relevant MeSH terms:

Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Poractant alfa; Pulmonary Surfactants; Respiratory System Agents