We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01709409
Recruitment Status : Completed
First Posted : October 18, 2012
Results First Posted : October 25, 2017
Last Update Posted : October 25, 2017
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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

Layout table for study information
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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   24 Weeks to 31 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01709409

Layout table for location information
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
Layout table for investigator information
Principal Investigator: Brigitte Lemyre, MD OHRI
Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01709409    
Other Study ID Numbers: Curosurf-01
First Posted: October 18, 2012    Key Record Dates
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:
Additional relevant MeSH terms:
Layout table for 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