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| Name | Class |
|---|---|
| Hamilton Health Sciences Corporation | OTHER |
| Sunnybrook Research Institute | OTHER |
| Women's and Children's Hospital, Australia | OTHER_GOV |
| Canadian Institutes of Health Research (CIHR) |
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Antenatal corticosteroids (ACS) reduce the risks of neonatal death and morbidities in preterm infants, such as respiratory distress syndrome.
The standard of care for pregnant people at risk of preterm birth includes 2 doses of Celestone (for a total of 24 mg in Canada, or 22.8 mg in Australia) to accelerate fetal lung maturity.
The investigators plan to conduct a randomized controlled trial to determine whether half the usual dose (12 mg in Canada, or 11.4 mg in Australia) of Celestone is non-inferior to the standard double doses.
Preterm infants are at risk of mortality and morbidity. Antenatal corticosteroids (ACS) reduce the risks of neonatal death and morbidities, such as respiratory distress syndrome.
The standard of care for pregnant people at risk of preterm birth includes 2 doses of Celestone to accelerate fetal lung maturity (total 24 mg in Canada, 22.8 mg in Australia). There are no published clinical trial data on the benefits or risks of a single dose of antenatal corticosteroid vs. standard double doses (Ninan et al JOGC 2020).
Pregnant people at 22 weeks and 0 days to < 34 weeks and 6 days' gestation at risk of preterm birth with a singleton or twin gestation who have received the first dose of Celestone and consented to the trial will be randomized to receive approximately 24 hours later either an experimental placebo injection (of normal saline) or the standard double dose of Celestone to determine whether the intervention is non-inferior for the primary outcome of a composite of perinatal mortality or substantial morbidity.
Please note: Based on Health Canada's' guidance the study phase is 'Other: Off-Label use'. However, on the clincaltrial.gov record, 'Phase 4' is selected as this is the most relevant phase and there is no option to select 'Other'.
Please note: McMaster University, Canada is the Canadian Regulatory Sponsor and Overall Sponsor, and the University of Adelaide Australia is the Australian Sponsor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-Dose Celestone | Experimental | Having already received the first dose of Celestone as part of eligibility criteria, participants randomized to the experimental "Single-Dose" arm will receive a similar appearing placebo injection. |
|
| Double-Dose Celestone | Active Comparator | Having already received the first dose of Celestone as part of eligibility criteria, participants randomized to the "Double-Dose" arm will receive the standard 2nd dose of Celestone injected intramuscularly (i.e. they will receive the standard double-dose regimen). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celestone + placebo | Drug | After the first intramuscular injection of Celestone, participants randomized to the "Placebo Comparator" group will receive 1 intramuscular injection of placebo. |
| Measure | Description | Time Frame |
|---|---|---|
| Perinatal Mortality or Substantial Neonatal Morbidity | Fetal death post-randomization or in hospital neonatal death OR => 1 of respiratory morbidity (requiring surfactant <=48 hrs of life), severe intraventricular hemorrhage (distending/beyond the ventricles, i.e. Grade 3 or 4), or severe bowel problem (necrotizing enterocolitis, Stage 2 or 3) | approximately 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Death or neurosensory/developmental impairment at 24 months | Death or neurosensory/developmental impairment at 24 months (+/- 6 months; accounting for gestation at birth), mood (anxiety/depression), behavior (aggression), etc as assessed by:
| approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of babies who received intubation and duration of invasive mechanical ventilation | Number of babies who received intubation and duration of invasive mechanical ventilation | approximately up to first 6 months of life |
| Number of babies who received, and duration of, supplemental oxygen (after resuscitation) and other ventilatory support |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah D McDonald, MD,MSc,FRCSC | Contact | 905-525-9140 | 26622 | mcdonals@mcmaster.ca |
| SNACS Coordinating Centre | Contact | SNACS@sunnybrook.ca |
| Name | Affiliation | Role |
|---|---|---|
| Sarah D McDonald, MD,MSc,FRCSC | McMaster University | Principal Investigator |
| Kellie Murphy, MD,MSc,FRCSC | University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary, Cumming School of Medicine | Recruiting | Calgary | Alberta | Canada | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32660867 | Background | Ninan K, Morfaw F, Murphy KE, Beyene J, McDonald SD. Neonatal and Maternal Outcomes of Lower Versus Standard Doses of Antenatal Corticosteroids for Women at Risk of Preterm Delivery: A Systematic Review of Randomized Controlled Trials. J Obstet Gynaecol Can. 2021 Jan;43(1):74-81. doi: 10.1016/j.jogc.2020.02.127. Epub 2020 Mar 26. |
| Label | URL |
|---|---|
| Neonatal and Maternal Outcomes of Lower Versus Standard Doses of Antenatal Corticosteroids for Women at Risk of Preterm Delivery: A Systematic Review of Randomized Controlled Trials | View source |
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An IPD is planned with trial leaders of another half dose Celestone study.
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| OTHER_GOV |
| Medical Research Future Fund | OTHER |
| University of Adelaide | OTHER |
Multicentre, blinded, pragmatic, 2 arm non-inferiority RCT
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| Celestone + Celestone | Drug | After the first intramuscular injection of Celestone, participants randomized to the "Active Comparator" group will receive 1 intramuscular injection of Celestone. |
|
Number of babies who received, and duration of, supplemental oxygen (after resuscitation) and other ventilatory support |
| approximately up to first 6 months of life |
| Number of babies with respiratory distress after the initial resuscitation/stabilization and main cause | Number of babies with respiratory distress after the initial resuscitation/stabilization and main cause (such as respiratory distress syndrome, pneumothorax/pneumomediastinum, pneumonia, transient tachypnea of the newborn, meconium aspiration syndrome, persistent pulmonary hypertension of the newborn) | approximately 1 month |
| Number of babies with Respiratory distress after the initial resuscitation/stabilization and main cause | Respiratory distress after the initial resuscitation/stabilization and main cause (such as respiratory distress syndrome, pneumothorax/pneumomediastinum, pneumonia, transient tachypnea of the newborn, meconium aspiration syndrome, persistent pulmonary hypertension of the newborn), | approximately at birth |
| Number of babies with hypoglycemia | Number of babies with hypoglycemia (low plasma glucose < 2.6 mmol/L between 30 minutes and 48 hours of life) | 48 hours |
| Number of babies with neonatal sepsis | Number of babies with neonatal sepsis within 7 days of birth, defined as a positive (bacterial, viral or fungal): blood culture or cerebrospinal fluid culture (or gram stain) or urine culture by sterile collection. | 7 days |
| Number of babies with severe retinopathy of prematurity needing treatment | Number of babies with severe retinopathy of prematurity defined as requiring vascular endothelial growth factor (VEGF) or laser or cryotherapy per the local guidelines | approximately first few months of life |
| Number of babies with patent ductus arteriosus (PDA) needing a closure procedure (surgery or device) | Number of babies with patent ductus arteriosus (PDA) needing a closure procedure (surgery or device) | up to 12 weeks after birth |
| Anthropometry at birth and at 24 months corrected age | Weight (in grams), length (in centimeters), and head circumference (in centimeters) for birth week as ACS can impact growth | at birth and at 24 months corrected age |
| Number of babies with severe late brain injury | Periventricular leukomalacia [PVL], i.e. cystic changes in white matter or porencephalic cysts or white matter changes diagnosed by ultrasound or MRI. | up to 20 weeks postnatal |
| Number of babies with chronic lung disease | Late respiratory morbidity, bronchopulmonary dysplasia (BPD), defined as requiring respiratory support or supplemental oxygen > 36 completed weeks' corrected gestation. | approximately up to first 6 months of life |
| Apgar score and cord blood pH | Apgar score (at 1 and 5 min) and lowest cord blood pH, regardless of whether arterial or venous. | approximately at birth |
| Length of stay in special care or an intensive care setting | Length of stay in an intensive care setting such as the neonatal intensive care unit (NICU). | approximately up to first 6 months of life |
| Use of postnatal corticosteroids | Use of systemic (intravenous or oral) postnatal corticosteroids and type (e.g. hydrocortisone, dexamethasone). | up to 20 weeks postnatal |
| Number of babies with longterm health care outcomes | Number of babies with reported longterm health care outcomes after initial hospital, such as hospitalizations, and other health care use. | approximately 5 -10 years |
| Number of babies with longterm education outcomes | Number of babies with reported longterm education or non-health data outcomes, collected through database linkage where possible. | approximately 5 -10 years |
| Number of participants with fetal death post-randomization or in hospital neonatal death OR => 1 of respiratory morbidity, severe intraventricular hemorrhage , or severe bowel problem | Fetal death post-randomization or in hospital neonatal death OR => 1 of respiratory morbidity (requiring surfactant <=48 hrs of life), severe intraventricular hemorrhage (distending/beyond the ventricles, i.e. Grade 3 or 4), or severe bowel problem (necrotizing enterocolitis, Stage 2 or 3) | approximately 1 month |
| Alberta Health Services; University of Alberta |
| Recruiting |
| Edmonton |
| Alberta |
| Canada |
| Royal Columbian Hospital | Not yet recruiting | New Westminster | British Columbia | Canada |
| Fraser Health, University of British Columbia; Jim Pattison Outpatient Care and Surgery Centre | Not yet recruiting | Surrey | British Columbia | Canada |
| University of British Columbia; BC Women's Hospital | Not yet recruiting | Vancouver | British Columbia | Canada |
| Victoria General Hospital | Not yet recruiting | Victoria | British Columbia | Canada |
| University of Manitoba, Health Sciences Centre | Not yet recruiting | Winnipeg | Manitoba | Canada |
| University of Manitoba; St. Boniface General Hospital | Not yet recruiting | Winnipeg | Manitoba | Canada |
| Dr. Everett Chalmers Regional Hospital | Recruiting | Fredericton | New Brunswick | Canada |
| The Moncton Hospital, Horizon Health Network | Recruiting | Moncton | New Brunswick | Canada |
| Memorial University, Eastern Health | Not yet recruiting | St. John's | Newfoundland and Labrador | Canada |
| Dalhousie University; Izaak Walton Killam Health | Recruiting | Halifax | Nova Scotia | Canada |
| McMaster University | Recruiting | Hamilton | Ontario | Canada |
| Queen's University, Kingston General Hospital Health Sciences Centre | Recruiting | Kingston | Ontario | Canada |
| Western University; London Health Sciences Centre, Victoria Hospital | Recruiting | London | Ontario | Canada |
| University of Ottawa; The Ottawa Hospital | Recruiting | Ottawa | Ontario | Canada |
| Mount Sinai Hospital | Recruiting | Toronto | Ontario | Canada |
| Sunnybrook Health Sciences Center | Recruiting | Toronto | Ontario | Canada |
| Hopital Maisonneuve Rosemont, CIUSSS de l'est de l'Ile de Montréal | Recruiting | Montreal | Quebec | H1T 2M4 | Canada |
| McGill University, McGill University Health Center, Royal Victoria Hospital | Recruiting | Montreal | Quebec | Canada |
| Sir Mortimer B. Davis Jewish General Hospital; McGill University | Not yet recruiting | Montreal | Quebec | Canada |
| The Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal | Recruiting | Montreal | Quebec | Canada |
| Université Laval, Centre de recherche du CHU de Québec | Recruiting | Québec | Quebec | Canada |
| (CIUSSS de l'Estrie-CHUS); Université de Sherbrooke | Recruiting | Sherbrooke | Quebec | Canada |
| University of Saskatchewan, Regina General Hospital | Not yet recruiting | Saskatoon | Saskatchewan | Canada |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D007752 | Obstetric Labor, Premature |
| D011248 | Pregnancy Complications |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D001623 | Betamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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