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Completed

NCT Number: NCT01709409

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

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.

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Key information

Conditions

Respiratory Distress Syndrome Female Urogenital Diseases and Pregnancy Complications Lung Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiration Disorders Respiratory Tract Diseases Urogenital Diseases

Age range

24 week–31 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Ottawa Hospital

Ottawa, Ontario, K1H8L6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Curosurf-Group1

Drug

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

BLES-group 2

Drug

Maximum of 3 doses are administered to infants with RDS

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

    Time frame: 48 hours

    • rate on ventilator ≤40 per minute and
    • mean airway pressure ≤ 10 cm H20 and
    • fi02 ≤ 30%

Secondary outcomes

  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

    • Extubation failure

  2. Curosurf-01

    Time frame: 36 weeks GA

    • Duration of first intubation (in hours/days)

  3. Curosurf-01

    Time frame: 36 weeks GA

    • Total duration of respiratory support (ventilator and nCPAP) and total number of days of oxygen requirement

  4. Curosurf-01

    Time frame: 36 weeks GA

    • Number of doses of surfactant received

  5. Curosurf-01

    Time frame: 36 weeks GA

    • Adverse events during or after administration of surfactant

  6. Curosurf-01

    Time frame: 36 Weeks GA

    • Bronchopulmonary dysplasia, defined as oxygen or respiratory support requirement at 36 weeks corrected GA

  7. Curosurf-01

    Time frame: 36 weeks GA

    • Mortality prior to discharge

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 18, 2012
Registry last updated
Oct 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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