Respiratory Distress SyndromePhase 3NCT01709409
A Multi-center Trial to Determine if Curosurf® Reduces the Duration of Mechanical Ventilation in Very Preterm Infants
A Phase 3 study testing Curosurf-Group1 and BLES-group 2 in people with Respiratory Distress Syndrome, run by Ottawa Hospital Research Institute at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 24 to 31 weeks
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- Curosurf-Group1 and BLES-group 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2013to Aug 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 31 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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
- Being tested
- Curosurf-Group1, BLES-group 2
- Keywords
- Prematurity
- Medical subject headings
- Respiratory Distress Syndrome, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curosurf-Group1Drug
Maximum of 3 doses are administered to infants diagnosed with RDS.
BLES-group 2Drug
Maximum of 3 doses are administered to infants with RDS
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: BLES-group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 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.
- Extubation failure
Measured: 36 weeks GA
Curosurf-01
- Duration of first intubation (in hours/days)
Measured: 36 weeks GA
Curosurf-01
- Total duration of respiratory support (ventilator and nCPAP) and total number of days of oxygen requirement
Measured: 36 weeks GA
Curosurf-01
- Number of doses of surfactant received
Measured: 36 weeks GA
Curosurf-01
- Adverse events during or after administration of surfactant
Measured: 36 weeks GA
Curosurf-01
- Bronchopulmonary dysplasia, defined as oxygen or respiratory support requirement at 36 weeks corrected GA
Measured: 36 Weeks GA
Curosurf-01
- Mortality prior to discharge
Measured: 36 weeks GA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study startMar 2013
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brigitte Lemyre, MD, Principal investigator, OHRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709409
- Sponsor's protocol ID
- Curosurf-01
- Status last verified
- Jun 2017
- First submitted
- 12 Oct 2012
- Last updated
- 25 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 28472058
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01709409
- Acronym / sponsor ID
- Curosurf-01
- Conditions
- Respiratory Distress Syndrome
- Keywords
- Prematurity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 18 Oct 2012 (estimated)
- Results
- Posted 25 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Curosurf (Group 1) | Experimental | Drug: Curosurf-Group1Surfactant(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. |
| BLES (Group 2) | Active comparator | Drug: BLES-group 2Surfactant(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. |
Who may qualify
- Ages
- 24 to 31 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curosurf-Group1Maximum of 3 doses are administered to infants diagnosed with RDS. | Drug | Curosurf (Group 1) |
| BLES-group 2Maximum of 3 doses are administered to infants with RDS | Drug | BLES (Group 2) |
Primary outcome
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
1. rate on ventilator ≤40 per minute and 2. mean airway pressure ≤ 10 cm H20 and 3. fi02 ≤ 30%
7 secondary outcomes
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
Curosurf-01
Time frame: 36 weeks GA
Curosurf-01
Time frame: 36 weeks GA
Curosurf-01
Time frame: 36 weeks GA
Curosurf-01
Time frame: 36 weeks GA
Curosurf-01
Time frame: 36 Weeks GA
Curosurf-01
Time frame: 36 weeks GA
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28472058Lemyre 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.
- Product informationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brigitte Lemyre, MD principal investigator
OHRI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Curosurf-Group1 and BLES-group 2 in people with Respiratory Distress Syndrome, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01709409, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2017.