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

Respiratory Distress Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01709409
• Other study ID #: Curosurf-01
• Status: Completed
• Phase: Phase 3
• First received: October 12, 2012
• Last updated: June 1, 2017
• Start date: March 2013
• Est. completion date: August 2016

Study information

• Verified date: June 2017
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Weeks to 31 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Drug:
• Curosurf-Group1
Maximum of 3 doses are administered to infants diagnosed with RDS.
• BLES-group 2
Maximum of 3 doses are administered to infants with RDS

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Lemyre B, Fusch C, Schmölzer 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	rate on ventilator =40 per minute and; mean airway pressure = 10 cm H20 and; fi02 = 30%	48 hours
Secondary	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	36 weeks GA
Secondary	Curosurf-01	2. Duration of first intubation (in hours/days)	36 weeks GA
Secondary	Curosurf-01	3. Total duration of respiratory support (ventilator and nCPAP) and total number of days of oxygen requirement	36 weeks GA
Secondary	Curosurf-01	4. Number of doses of surfactant received	36 weeks GA
Secondary	Curosurf-01	5. Adverse events during or after administration of surfactant	36 weeks GA
Secondary	Curosurf-01	6. Bronchopulmonary dysplasia, defined as oxygen or respiratory support requirement at 36 weeks corrected GA	36 Weeks GA
Secondary	Curosurf-01	7. Mortality prior to discharge	36 weeks GA

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