Preterm BirthPhase 4SNACSNCT05114096
Single Dose of Antenatal Corticosteroids for Pregnancies at Risk of Preterm Delivery (SNACS)
A Phase 4 study testing Celestone + Celestone in people with Preterm Birth and Premature Birth, run by McMaster University at 25 sites in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Preterm Birth, Premature Birth, Complication of Prematurity
- What is being tested?
- Celestone + Celestone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,254 participants
- Where
- 25 sitesCanada
- Study dates
- 20 Jul 2023to 31 Dec 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
25 sites in 1 country. Contact the study team or a site near you to ask about taking part.
SNACS Coordinating Centre contact
25 sites in 1 country
Canada25 sites, 25 recruiting
- Recruiting
University of Calgary, Cumming School of Medicine
Calgary, Alberta
- Recruiting
Alberta Health Services; University of Alberta
Edmonton, Alberta
- Recruiting
Dr. Everett Chalmers Regional Hospital
Fredericton, New Brunswick
- Recruiting
Dalhousie University; Izaak Walton Killam Health
Halifax, Nova Scotia
- Recruiting
McMaster University
Hamilton, Ontario
- Recruiting
Queen's University, Kingston General Hospital Health Sciences Centre
Kingston, Ontario
- Recruiting
Western University; London Health Sciences Centre, Victoria Hospital
London, Ontario
- Recruiting
The Moncton Hospital, Horizon Health Network
Moncton, New Brunswick
- Recruiting
Hopital Maisonneuve Rosemont, CIUSSS de l'est de l'Ile de Montréal
Montreal, Quebec, H1T 2M4
- Recruiting
McGill University, McGill University Health Center, Royal Victoria Hospital
Montreal, Quebec
- Not yet recruiting
Sir Mortimer B. Davis Jewish General Hospital; McGill University
Montreal, Quebec
- Recruiting
The Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal
Montreal, Quebec
- Not yet recruiting
Royal Columbian Hospital
New Westminster, British Columbia
- Recruiting
University of Ottawa; The Ottawa Hospital
Ottawa, Ontario
- Recruiting
Université Laval, Centre de recherche du CHU de Québec
Québec, Quebec
- Not yet recruiting
University of Saskatchewan, Regina General Hospital
Saskatoon, Saskatchewan
- Recruiting
(CIUSSS de l'Estrie-CHUS); Université de Sherbrooke
Sherbrooke, Quebec
- Not yet recruiting
Memorial University, Eastern Health
St. John's, Newfoundland and Labrador
- Not yet recruiting
Fraser Health, University of British Columbia; Jim Pattison Outpatient Care and Surgery Centre
Surrey, British Columbia
- Recruiting
Mount Sinai Hospital
Toronto, Ontario
- Recruiting
Sunnybrook Health Sciences Center
Toronto, Ontario
- Not yet recruiting
University of British Columbia; BC Women's Hospital
Vancouver, British Columbia
- Not yet recruiting
Victoria General Hospital
Victoria, British Columbia
- Not yet recruiting
University of Manitoba, Health Sciences Centre
Winnipeg, Manitoba
- Not yet recruiting
University of Manitoba; St. Boniface General Hospital
Winnipeg, Manitoba
About this study
Official title: 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.
Read the 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.
- Conditions
- Preterm Birth, Premature Birth, Complication of Prematurity, Obstetric Labor, Premature, Pregnancy Complications
- Being tested
- Celestone + placebo, Celestone + Celestone
- Keywords
- Premature birth, Preterm birth, Obstetric labour, Betamethasone, Betamethasone Valerate, Betamethasone-17,21-dipropionate, Betamethasone benzoate, Betamethasone sodium phosphate, Anti-Inflammatory Agents, Glucocorticoids, Hormones, Hormones, Hormone Substitutes and Hormone Antagonists, Physiological Effect of Drugs, Anti-Asthmatic Agents, Respiratory System Agents
- Medical subject headings
- Premature Birth, Obstetric Labor, Premature, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celestone + placeboDrug
After the first intramuscular injection of Celestone, participants randomized to the "Placebo Comparator" group will receive 1 intramuscular injection of placebo.
Celestone + CelestoneDrug
After the first intramuscular injection of Celestone, participants randomized to the "Active Comparator" group will receive 1 intramuscular injection of Celestone.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Celestone + placebo |
| 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). Receives: Drug: Celestone + Celestone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: approximately 1 month
Secondary outcomes (1)
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:
- Ages and Stages Questionnaire-3 (ASQ)
- Child Behavior Checklist: 4 subscales
- Physician diagnosis of cerebral palsy (parent report).
Measured: approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start20 Jul 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre, blinded, pragmatic, 2 arm non-inferiority RCT
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,254 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation, Sunnybrook Research Institute, Women's and Children's Hospital, Australia, Canadian Institutes of Health Research (CIHR), Medical Research Future Fund, University of Adelaide
- Responsible party
- Sponsor
- Investigators
- Sarah D McDonald, MD,MSc,FRCSC, Principal investigator, McMaster UniversityKellie Murphy, MD,MSc,FRCSC, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114096
- Sponsor's protocol ID
- 3764
- Acronym
- SNACS
- Status last verified
- Sep 2025
- First submitted
- 12 Oct 2021
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: An IPD is planned with trial leaders of another half dose Celestone study.
Publications
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.
PubMed 32660867
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose of Antenatal Corticosteroids (SNACS) Randomized Controlled Trial for Pregnancies at Risk of Preterm Delivery: To Keep Babies and Children Safe
- ClinicalTrials.gov ID
- NCT05114096
- Acronym / sponsor ID
- SNACS / 3764
- Conditions
- Preterm Birth, Premature Birth, Complication of Prematurity, Obstetric Labor, Premature, Pregnancy Complications
- Keywords
- Premature birth, Preterm birth, Obstetric labour, Betamethasone, Betamethasone Valerate, Betamethasone-17,21-dipropionate, Betamethasone benzoate, Betamethasone sodium phosphate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,254 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation, Sunnybrook Research Institute, Women's and Children's Hospital, Australia, Canadian Institutes of Health Research (CIHR), Medical Research Future Fund, University of Adelaide
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 9 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicentre, blinded, pragmatic, 2 arm non-inferiority RCT
| Arm | Type | Receives |
|---|---|---|
| Single-Dose Celestone | Experimental | Drug: Celestone + placeboHaving 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 | Drug: Celestone + CelestoneHaving 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). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Celestone + placeboAfter the first intramuscular injection of Celestone, participants randomized to the "Placebo Comparator" group will receive 1 intramuscular injection of placebo. | Drug | Single-Dose Celestone |
| Celestone + CelestoneAfter the first intramuscular injection of Celestone, participants randomized to the "Active Comparator" group will receive 1 intramuscular injection of Celestone. | Drug | Double-Dose Celestone |
Primary outcome
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)
1 secondary outcome
Death or neurosensory/developmental impairment at 24 months
Time frame: approximately 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Background: PubMed 32660867Ninan 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.
- 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 TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No. An IPD is planned with trial leaders of another half dose Celestone study.
Related trials for Preterm Birth
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
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.
SNACS Coordinating Centre contact
Sarah D McDonald, MD,MSc,FRCSC principal investigator
McMaster University
Kellie Murphy, MD,MSc,FRCSC principal investigator
University of Toronto
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Celestone + Celestone in people with Preterm Birth and Premature Birth, run by McMaster University at 25 sites 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 5 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: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah D McDonald, MD,MSc,FRCSC (905-525-9140 ext. 26622, mcdonals@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perinatal Mortality or Substantial Neonatal Morbidity (time frame: approximately 1 month). 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 NCT05114096, 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 7 Jan 2026.