- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05114096
Single Dose of Antenatal Corticosteroids for Pregnancies at Risk of Preterm Delivery (SNACS) (SNACS)
Single Dose of Antenatal Corticosteroids (SNACS) Randomized Controlled Trial for Pregnancies at Risk of Preterm Delivery: To Keep Babies and Children Safe
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Sarah D McDonald, MD,MSc,FRCSC
- Phone Number: 26622 905-525-9140
- Email: mcdonals@mcmaster.ca
Study Contact Backup
- Name: SNACS Coordinating Centre
- Email: SNACS@sunnybrook.ca
Study Locations
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New South Wales
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Newcastle, New South Wales, Australia
- Not yet recruiting
- John Hunter Hospital
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Newcastle, New South Wales, Australia
- Not yet recruiting
- The University of Newcastle
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Randwick, New South Wales, Australia
- Not yet recruiting
- The Royal Hospital for Women
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Sydney, New South Wales, Australia
- Not yet recruiting
- The University of New South Wales, St George Hospital
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Westmead, New South Wales, Australia
- Not yet recruiting
- University of Sydney; Westmead Institute for Maternal Fetal Medicine, Westmead Hospital
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Northern Territory
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Tiwi, Northern Territory, Australia
- Not yet recruiting
- Royal Darwin Hospital
-
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Queensland
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Herston, Queensland, Australia
- Not yet recruiting
- Royal Brisbane & Women's Hospital
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Ipswich, Queensland, Australia
- Not yet recruiting
- University of Queensland and Ipswich Hospital
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South Brisbane, Queensland, Australia
- Not yet recruiting
- Mater Centre for Maternal Fetal Medicine
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South Brisbane, Queensland, Australia
- Not yet recruiting
- The University of Queensland; Mater Research Institute/University of Queensland
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Townsville, Queensland, Australia
- Not yet recruiting
- Townsville Hospital and Health Services
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South Australia
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North Adelaide, South Australia, Australia
- Not yet recruiting
- University of Adelaide; Women's & Children's Hospital
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Tasmania
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Hobart, Tasmania, Australia
- Not yet recruiting
- Royal Hobart Hospital
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Victoria
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Clayton, Victoria, Australia
- Not yet recruiting
- Moorabbin Hospital, Monash Health
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Heidelberg, Victoria, Australia
- Not yet recruiting
- University of Melbourne; Mercy Hospital for Women
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Parkville, Victoria, Australia
- Not yet recruiting
- The Royal Women's Hospital; University of Melbourne
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Saint Albans, Victoria, Australia
- Not yet recruiting
- The University of Melbourne; Joan Kirner Women's & Children's Sunshine Hospital
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-
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Alberta
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Calgary, Alberta, Canada
- Not yet recruiting
- University of Calgary, Cumming School of Medicine
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Edmonton, Alberta, Canada
- Not yet recruiting
- Alberta Health Services; University of Alberta
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British Columbia
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New Westminster, British Columbia, Canada
- Not yet recruiting
- Royal Columbian Hospital
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Surrey, British Columbia, Canada
- Not yet recruiting
- Fraser Health, University of British Columbia; Jim Pattison Outpatient Care and Surgery Centre
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Vancouver, British Columbia, Canada
- Not yet recruiting
- University of British Columbia; BC Women's Hospital
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Victoria, British Columbia, Canada
- Not yet recruiting
- Victoria General Hospital
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Manitoba
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Winnipeg, Manitoba, Canada
- Not yet recruiting
- University of Manitoba, Health Sciences Centre
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Winnipeg, Manitoba, Canada
- Not yet recruiting
- University of Manitoba; St. Boniface General Hospital
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New Brunswick
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Fredericton, New Brunswick, Canada
- Not yet recruiting
- Dr. Everett Chalmers Regional Hospital
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Moncton, New Brunswick, Canada
- Not yet recruiting
- The Moncton Hospital, Horizon Health Network
-
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada
- Not yet recruiting
- Memorial University, Eastern Health
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Nova Scotia
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Halifax, Nova Scotia, Canada
- Not yet recruiting
- Dalhousie University
-
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Ontario
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Hamilton, Ontario, Canada
- Recruiting
- McMaster University
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Kingston, Ontario, Canada
- Not yet recruiting
- Queen's University, Kingston General Hospital Health Sciences Centre
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London, Ontario, Canada
- Not yet recruiting
- Western University; London Health Sciences Centre, Victoria Hospital
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Ottawa, Ontario, Canada
- Not yet recruiting
- University of Ottawa; The Ottawa Hospital
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Toronto, Ontario, Canada
- Not yet recruiting
- Mount Sinai Hospital
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Toronto, Ontario, Canada
- Not yet recruiting
- Sunnybrook Health Sciences Center
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Quebec
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Montréal, Quebec, Canada
- Not yet recruiting
- McGill University, McGill University Health Center, Royal Victoria Hospital
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Montréal, Quebec, Canada
- Not yet recruiting
- Sir Mortimer B. Davis Jewish General Hospital; McGill University
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Montréal, Quebec, Canada
- Not yet recruiting
- The Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal
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Québec City, Quebec, Canada
- Not yet recruiting
- Université Laval, Centre de recherche du CHU de Québec
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Sherbrooke, Quebec, Canada
- Not yet recruiting
- (CIUSSS de l'Estrie-CHUS); Université de Sherbrooke
-
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Saskatchewan
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Saskatoon, Saskatchewan, Canada
- Not yet recruiting
- University of Saskatchewan, Regina General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pregnant people, aged 18 to 55 years old, at risk of preterm birth with a singleton or twins between 22 weeks and 0 days and <34 weeks and 6 days gestation who have received only a single dose of Celestone within 24 hours
- Capable of giving informed, written consent.
Exclusion Criteria:
- Contraindication to corticosteroids
- Systemic corticosteroids for medical conditions during the pregnancy (e.g. lupus, severe asthma, Covid, etc).
- Previous participation in this trial (in a previous pregnancy)
- Known severe/life-threatening fetal or pregnant patient condition (e.g. fetal congenital/chromosomal abnormality)
- Demise of one or more fetuses after 14 weeks and 0 days
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single-Dose Celestone
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.
|
After the first intramuscular injection of Celestone, participants randomized to the "Placebo Comparator" group will receive 1 intramuscular injection of placebo.
|
Active Comparator: Double-Dose Celestone
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).
|
After the first intramuscular injection of Celestone, participants randomized to the "Active Comparator" group will receive 1 intramuscular injection of Celestone.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perinatal Mortality or Substantial Neonatal Morbidity
Time Frame: approximately 1 month
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Death or neurosensory/developmental impairment at 24 months
Time Frame: approximately 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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of babies who received intubation and duration of invasive mechanical ventilation
Time Frame: approximately up to first 6 months of life
|
Number of babies who received intubation and duration of invasive mechanical ventilation
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approximately up to first 6 months of life
|
Number of babies who received, and duration of, supplemental oxygen (after resuscitation) and other ventilatory support
Time Frame: approximately up to first 6 months of life
|
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 hypoglycemia
Time Frame: 48 hours
|
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
Time Frame: 7 days
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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
Time Frame: approximately first few months of life
|
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)
Time Frame: up to 12 weeks after birth
|
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
Time Frame: at birth and at 24 months corrected age
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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
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Number of babies with severe late brain injury
Time Frame: up to 20 weeks postnatal
|
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
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Number of babies with chronic lung disease
Time Frame: approximately up to first 6 months of life
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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
Time Frame: approximately at birth
|
Apgar score (at 1 and 5 min) and lowest cord blood pH, regardless of whether arterial or venous.
|
approximately at birth
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Use of postnatal corticosteroids
Time Frame: up to 20 weeks postnatal
|
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
Time Frame: approximately 5 -10 years
|
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
Time Frame: approximately 5 -10 years
|
Number of babies with reported longterm education or non-health data outcomes, collected through database linkage where possible.
|
approximately 5 -10 years
|
Number of babies with respiratory distress after the initial resuscitation/stabilization and main cause
Time Frame: approximately 1 month
|
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
Time Frame: approximately at birth
|
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
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Length of stay in special care or an intensive care setting
Time Frame: approximately up to first 6 months of life
|
Length of stay in an intensive care setting such as the neonatal intensive care unit (NICU).
|
approximately up to first 6 months of life
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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
Time Frame: approximately 1 month
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sarah D McDonald, MD,MSc,FRCSC, McMaster University
- Principal Investigator: Kellie Murphy, MD,MSc,FRCSC, University of Toronto
- Principal Investigator: Jodie Dodd, MD, The University of Adelaide, Australia
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Glucocorticoids
- Premature birth
- Preterm birth
- Hormones
- Anti-Asthmatic Agents
- Anti-Inflammatory Agents
- Respiratory System Agents
- Betamethasone
- Betamethasone Valerate
- Betamethasone-17,21-dipropionate
- Physiological Effect of Drugs
- Obstetric labour
- Betamethasone benzoate
- Betamethasone sodium phosphate
- Hormones, Hormone Substitutes and Hormone Antagonists
Additional Relevant MeSH Terms
- Obstetric Labor Complications
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Premature Birth
- Pregnancy Complications
- Obstetric Labor, Premature
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Asthmatic Agents
- Respiratory System Agents
- Betamethasone
- Betamethasone Valerate
- Betamethasone-17,21-dipropionate
- Betamethasone benzoate
- Betamethasone sodium phosphate
Other Study ID Numbers
- 3764
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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