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

NCT01709409 | Completed Phase 3 Results DMC

• 1 other identifier: Curosurf-01
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (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

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

  48 hours

Secondary Outcomes (7)

• 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.

  36 weeks GA

• Curosurf-01

  36 weeks GA

• Curosurf-01

  36 weeks GA

• Curosurf-01

  36 weeks GA

• Curosurf-01

  36 weeks GA

Study Arms (2)

Curosurf (Group 1)

EXPERIMENTAL

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

BLES (Group 2)

ACTIVE COMPARATOR

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

Interventions

Curosurf-Group1 DRUG

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

Curosurf (Group 1)

BLES-group 2 DRUG

Maximum of 3 doses are administered to infants with RDS

BLES (Group 2)

Eligibility Criteria

• Age: 24 Weeks - 31 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants born between 24+0 and 31+6 weeks gestational age, admitted to the study centers
• Infants with RDS requiring intubation and surfactant therapy within 48 hours after birth

You may not qualify if:

• Any infant more than 48 hours of age
• Any infant with a pulmonary hemorrhage
• Any infant with life-threatening congenital anomaly or one that is considered non-viable
• Any infant on rescue high frequency ventilation
• Any infant known to require early intubation and ventilation for surgical treatment of a congenital anomaly
• Any infant with anomalies of the upper or lower airway or mandible precluding use of nCPAP
• Any infant born after prolonged premature rupture of membranes (\<22 weeks GA or \>28 days prior to delivery)
• A parent/LAR who is incapable of, or unwilling, to give consent
• Participation in another clinical trial of any placebo, drug, biological, or device conducted under the provisions of a protocol
• Any other reason as deemed significant by the Investigator

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H8L6, Canada

Location

Related Publications (1)

• 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.

  PMID: 28472058 RESULT

Related Links

• Product information

MeSH Terms

Conditions

Respiratory Distress Syndrome; Premature Birth

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: Dr. Brigitte Lemyre
• Organization: OHRI

blemyre@toh.on.ca

613-737-8899

Study Officials

• Brigitte Lemyre, MD

  OHRI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2012
• First Posted: October 18, 2012
• Study Start: March 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 25, 2017
• Results First Posted: October 25, 2017

Record last verified: 2017-06

Locations

CA (1)