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A Multi-center Trial to Determine if Curosurf® Reduces the Duration of Mechanical Ventilation in Infants 24+0 to 29+6 Weeks Gestational Age

This study is not yet open for participant recruitment.
Verified October 2012 by Ottawa Hospital Research Institute
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01709409
First received: October 12, 2012
Last updated: October 16, 2012
Last verified: October 2012
History of Changes
  Purpose

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 licensed in other countries around the world but is not licensed as yet, in Canada.

Babies born between 24 and 30 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. The current standard treatment is a surfactant called BLES. As Curosurf is less viscous and more potent (therefore requiring a smaller dose), the investigators hypothesize that it will lead to quicker removal from the respirator.

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 Intervention Phase
Respiratory Distress Syndrome
 Drug: Curosurf-Group1
 Phase 3

Study Type: Interventional
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 29+6 Weeks Gestational Age

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies
U.S. FDA Resources

Further study details as provided by Ottawa Hospital Research Institute:

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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 88
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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, as per the standard surfactant policy of the NICU.
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: Curosurf-Group1
Maximum of 3 doses are administered to infants diagnosed with RDS, as per the standard surfactant policy of the NICU.

  Eligibility

Ages Eligible for Study:   24 Weeks to 29 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Infants born between 24+0 and 29+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 a high frequency ventilator
  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 >14 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01709409

Contacts
Contact: Brigitte Lemyre, MD 6137378899 ext 71882 blemyre@ottawahospital.on.ca
Contact: Lynne Cullen, RN 6137377600 ext 3782 lcullen@cheo.on.ca

Locations
Canada, Ontario
The Ottawa Hospital Not yet recruiting
Ottawa, Ontario, Canada, K1H8L6
Contact: Lynne Cullen, RN     6137377600 ext 3782     lcullen@cheo.on.ca    
Contact: Samantha Somers, BA     6137377600 ext 2794     ssomers@cheo.on.ca    
Principal Investigator: Brigitte Lemyre, MD            
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Brigitte Lemyre, MD OHRI
  More Information

Additional Information:
Product infomration  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01709409     History of Changes
Other Study ID Numbers: Curosurf-01
Study First Received: October 12, 2012
Last Updated: October 16, 2012
Health Authority: Canada: Health Canada

Keywords provided by Ottawa Hospital Research Institute:
Prematurity

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
 Infant, Newborn, Diseases
Poractant alfa
Pulmonary Surfactants
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013