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

NCT ID: NCT01709409

Last Updated: 2017-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2016-08-31

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.

Conditions

Respiratory Distress Syndrome

Keywords

Prematurity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Curosurf-Group1

Intervention Type: DRUG

Maximum of 3 doses are administered to infants diagnosed with RDS.

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.

Group Type: ACTIVE_COMPARATOR

BLES-group 2

Intervention Type: DRUG

Maximum of 3 doses are administered to infants with RDS

Interventions

Curosurf-Group1

Maximum of 3 doses are administered to infants diagnosed with RDS.

Intervention Type: DRUG

BLES-group 2

Maximum of 3 doses are administered to infants with RDS

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 24 Weeks
• Maximum Eligible Age: 31 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brigitte Lemyre, MD

Role: PRINCIPAL_INVESTIGATOR

OHRI

Locations

The Ottawa Hospital

Ottawa, Ontario, Canada

Countries

Canada

References

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.

Reference Type: RESULT

PMID: 28472058 (View on PubMed)

Related Links

http://www.curosurf.com/

Product information

Other Identifiers

Curosurf-01

Identifier Type: -

Identifier Source: org_study_id