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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curosurf-Group1 | Drug | Maximum of 3 doses are administered to infants diagnosed with RDS. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Curosurf-01 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brigitte Lemyre, MD | OHRI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital | Ottawa | Ontario | K1H8L6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28472058 | Result | 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. |
| Label | URL |
|---|---|
| Product information | View source |
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One patient in the Curosurf group was found to have an exclusion criteria after randomization and was excluded (he did not receive the assigned treatment).
Three university-affiliated tertiary NICUs recruited patients between March 2013 and December 2015. 560 patients were screening for eligibility.
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| ID | Title | Description |
|---|---|---|
| FG000 | Curosurf (Group 1) | Surfactant(Curosurf in this arm) was given for treatment of established RDS. The treatment dose for Curosurf® was 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 was a maximum of 3 doses in the study. |
| FG001 | BLES (Group 2) | Surfactant(BLES in this arm) was given for treatment of established RDS. The treatment dose for BLES was 5 ml/kg. given by endotracheal method. There was a maximum of 3 doses in the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Curosurf-Group1: Maximum of 3 doses are administered to infants diagnosed with RDS. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
| Posted | Count of Participants | Participants | 48 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Curosurf (Group 1) | Surfactant(Curosurf in this arm) was given for treatment of established RDS. The treatment dose for Curosurf® was 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 was a maximum of 3 doses in the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| severe airway obstruction | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pulmonary interstitial emphysema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brigitte Lemyre | OHRI | 613-737-8899 | 71882 | blemyre@toh.on.ca |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D007752 | Obstetric Labor, Premature |
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| BLES-group 2 | Drug | Maximum of 3 doses are administered to infants with RDS |
|
2. Duration of first intubation (in hours/days) |
| 36 weeks GA |
| Curosurf-01 | 3. Total duration of respiratory support (ventilator and nCPAP) and total number of days of oxygen requirement | 36 weeks GA |
| Curosurf-01 | 4. Number of doses of surfactant received | 36 weeks GA |
| Curosurf-01 | 5. Adverse events during or after administration of surfactant | 36 weeks GA |
| Curosurf-01 | 6. Bronchopulmonary dysplasia, defined as oxygen or respiratory support requirement at 36 weeks corrected GA | 36 Weeks GA |
| Curosurf-01 | 7. Mortality prior to discharge | 36 weeks GA |
| BG001 | 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. BLES-group 2: Maximum of 3 doses are administered to infants with RDS |
| BG002 | Total | Total of all reporting groups |
| weeks gestational age |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| fraction of inspired oxygen | Median | Inter-Quartile Range | % of inspired oxygen |
|
|
|
| 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 | Not Posted | 36 weeks GA | Participants |
| Secondary | Curosurf-01 | 2. Duration of first intubation (in hours/days) | Not Posted | 36 weeks GA | Participants |
| Secondary | Curosurf-01 | 3. Total duration of respiratory support (ventilator and nCPAP) and total number of days of oxygen requirement | Not Posted | 36 weeks GA | Participants |
| Secondary | Curosurf-01 | 4. Number of doses of surfactant received | Not Posted | 36 weeks GA | Participants |
| Secondary | Curosurf-01 | 5. Adverse events during or after administration of surfactant | Not Posted | 36 weeks GA | Participants |
| Secondary | Curosurf-01 | 6. Bronchopulmonary dysplasia, defined as oxygen or respiratory support requirement at 36 weeks corrected GA | Not Posted | 36 Weeks GA | Participants |
| Secondary | Curosurf-01 | 7. Mortality prior to discharge | Not Posted | 36 weeks GA | Participants |
| 5 |
| 42 |
| 1 |
| 42 |
| EG001 | BLES (Group 2) | Surfactant(BLES in this arm) was given for treatment of established RDS. The treatment dose for BLES was 5 ml/kg. given by endotracheal method. There was a maximum of 3 doses in the study. | 11 | 45 | 1 | 45 |
| air leak | Reproductive system and breast disorders | Systematic Assessment |
|
| pulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| needing CPR | Cardiac disorders | Systematic Assessment |
|
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| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |