Preterm BirthPhase 3SNACS PilotNCT04494529
Single Dose Antenatal Corticosteroids (SNACS) for Women at Risk of Preterm Birth
A Phase 3 study testing 24 mg betamethasone in people with Preterm Birth and Complication of Prematurity, run by McMaster University at 1 site in Canada.
Trial summary
Antenatal corticosteroids (ACS) reduce the risks of neonatal death and morbidities, such as respiratory distress syndrome, in preterm infants. Standard of care for women at risk of preterm birth includes 2 doses of 12 mg betamethasone (for a total of 24 mg) to accelerate fetal lung maturity. Read more about this study
- Who is it for?
- Ages 16 to 55 years, women only
- Conditions the study is for
- Preterm Birth, Complication of Prematurity, Obstetric Labor, Premature
- What is being tested?
- 24 mg betamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2021to 31 Aug 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 16 to 55 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pregnant women at risk of preterm birth with a singleton or twins between =>22+0/7 and <=34+6/7 weeks' gestation
- Pregnant with either singletons or twins
- Has already received the first dose of 12 mg intramuscular betamethasone within the past 24 hours
- All fetuses are alive and without compromise as per ultrasound or fetal heart monitor
- Is capable of giving informed, written consent in English
Who cannot join
- Any contraindications to receiving corticosteroids
- Requires chronic doses of corticosteroids secondary to a medical condition (e.g. systemic lupus erythematosus, severe asthma, congenital adrenal hyperplasia, etc.)
- Received any prior doses of antenatal corticosteroids except for the 1st dose of 12 mg intramuscular betamethasone
- Had any previous participation in this trial
- Pregnant with a fetus with severe congenital anomaly (e.g. anencephaly, transposition of the great arteries, etc.) or major chromosomal abnormalities (e.g. Trisomy 18, Trisomy 21, etc.)
- Pregnant with monoamniotic/monochorionic (Mono/Mono) twins
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Dose Antenatal Corticosteroids (SNACS) Pilot Randomized Control Trial for Women at Risk of Preterm Birth
Antenatal corticosteroids (ACS) reduce the risks of neonatal death and morbidities, such as respiratory distress syndrome, in preterm infants.
Standard of care for women at risk of preterm birth includes 2 doses of 12 mg betamethasone (for a total of 24 mg) to accelerate fetal lung maturity.
We plan to conduct a pilot clinical trial to determine the feasibility of a trial comparing half the usual dose (total 12 mg) of betamethasone to the standard double dose (total 24 mg) of betamethasone.
The results of this pilot will be combined with the full-scale RCT (NCT05114096) for which we have received funding from the Canadian Institutes of Health Research (CIHR).
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.
Standard of care for women at risk of preterm birth includes 2 doses of 12 mg betamethasone (for a total of 24 mg) to accelerate fetal lung maturity. There are no published clinical trial data on the benefits or risks of a single dose of antenatal corticosteroid vs. standard double doses.
Pilot trials are now viewed as an "almost essential prerequisite" to large, expensive, full scale studies. Thus, we plan to conduct a pilot clinical trial to determine the feasibility of a trial comparing half the usual dose (12 mg of betamethasone + placebo) to the standard double dose (12 mg + 12 mg of betamethasone), as well as the feasibility of the study protocol. Secondary outcomes will include process outcomes and pilot clinical outcomes, that will be combined with the full-scale RCT for which we have received funding from CIHR.
We plan to conduct a 24-month corrected gestational age follow-up, which will consist principally of 2 validated parent-filled questionnaires:
- Ages and Stages Questionnaire-3 (ASQ)
- Child Behavior Checklist
- A single question parent report of whether there has been a physician diagnosis of cerebral palsy. (recommended by our parent partners)
- Conditions
- Preterm Birth, Complication of Prematurity, Obstetric Labor, Premature, Obstetric Labor Complications, Pregnancy Complications
- Being tested
- 12 mg betamethasone + placebo, 24 mg betamethasone
- Keywords
- Premature birth, Preterm birth, Obstetric labor, Betamethasone Valerate, Betamethasone-17,21-dipropionate, Betamethasone benzoate; Betamethasone sodium phosphate, Anti-Inflammatory Agents, Glucocorticoids, Hormones, Hormone Substitutes, Hormone Antagonists, Physiological Effect of Drugs, Anti-Asthmatic Agents, Respiratory System Agents
- Medical subject headings
- Premature Birth, Obstetric Labor, Premature, Obstetric Labor Complications, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12 mg betamethasone + placeboDrug
After the first intramuscular injection of 12 mg of betamethasone, participants randomized to the "Placebo Comparator" group will receive 1 intramuscular injection of placebo.
24 mg betamethasoneDrug
After the first intramuscular injection of 12 mg of betamethasone, participants randomized to the "Active Comparator" group will receive the standard 2nd intramuscular injection of 12 mg of betamethasone.
| Study group | Role | What they receive |
|---|---|---|
| Single-Dose (12 mg betamethasone + placebo) | Placebo comparator | The standard course of betamethasone consists of 2 intramuscular injections of 12 mg betamethasone 24 hours apart for a total dose of 24 mg. Before enrolment and randomization in the SNACS trial, all women will have received a first 12 mg injection of betamethasone according to local hospital protocols. After this first injection, randomization is performed.
Participants randomized to the experimental "Single-Dose" arm will receive a similar appearing placebo injection instead of the standard 2nd dose of 12 mg of betamethasone (i.e. they will receive the experimental single-dose regimen, total 12 mg of betamethasone only from the first injection). Receives: Drug: 12 mg betamethasone + placebo |
| Double-Dose (12 mg betamethasone + 12 mg betamethasone) | Active comparator | The standard course of betamethasone consists of 2 intramuscular injections of 12 mg betamethasone 24 hours apart for a total dose of 24 mg. Before enrolment and randomization in the SNACS trial, all women will have received a first 12 mg injection of betamethasone according to local hospital protocols. After this first injection, randomization is performed.
Participants randomized to the "Double-Dose" arm will receive the standard 2nd dose of 12 mg of betamethasone injected intramuscularly (i.e. they will receive the standard double-dose regimen, total 24 mg of betamethasone). Receives: Drug: 24 mg betamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of conducting a full-scale trial
Feasibility of conducting a full-scale trial will be defined as => 50% recruitment of approached participants
Measured: 5-6 months
Feasibility of the study protocol
Feasibility of the study intervention will be defined as => 98% compliance with the protocol
Measured: 5-6 months
Secondary outcomes (18)
Process outcomes
The proportions of patients who: will be approached by the circle of care, and will agree to be approached by the research team, and will agree to participate
Measured: 5-6 months
Neonatal mortality rates
Pilot clinical data on neonatal mortality, from medical records
Measured: 5-6 months
Respiratory morbidity rates
Pilot clinical data on respiratory morbidity, from medical records
Measured: 5-6 months
Severe intraventricular haemorrhage rates
Pilot clinical data on severe intraventricular haemorrhage, from medical records
Measured: 5-6 months
Rates of severe bowel problems due to necrotizing enterocolitis
Pilot clinical data on severe bowel problems due to necrotizing enterocolitis, from medical records
Measured: 5-6 months
Duration of mechanical ventilation requiring an endotracheal tube
Pilot clinical data on duration of mechanical ventilation requiring an endotracheal tube, from medical records
Measured: 5-6 months
Need for supplemental oxygen and duration
Pilot clinical data on need for supplemental oxygen and duration, from medical records
Measured: 5-6 months
Late respiratory morbidity (i.e. bronchopulmonary dysplasia) rates
Pilot clinical data on late respiratory morbidity (i.e. bronchopulmonary dysplasia), from medical records
Measured: 5-6 months
Early neonatal sepsis rates
Pilot clinical data on early neonatal sepsis, from medical records
Measured: 5-6 months
Severe late brain injury (periventricular leukomalacia) rates
Pilot clinical data on severe late brain injury (periventricular leukomalacia), from medical records
Measured: 5-6 months
Intrauterine fetal demise rates
Pilot clinical data on intrauterine fetal demise, from medical records
Measured: 5-6 months
Duration of ventilatory support not requiring an endotracheal tube
Pilot clinical data on duration of ventilatory support not requiring an endotracheal tube, from medical records
Measured: 5-6 months
Rates of hypotension < 48 hours of life requiring treatment with hydrocortisone or inotropic medications
Pilot clinical data on hypotension < 48 hours of life requiring treatment with hydrocortisone or inotropic medications, from medical records
Measured: 5-6 months
Length of stay in neonatal intensive care unit
Pilot clinical data on length of stay in neonatal intensive care unit, from medical records
Measured: 5-6 months
Anthropometry composite (<10% of expected weight, length, or head circumference for birth week)
Pilot clinical data on anthropometry (<10% of expected weight, length, or head circumference for birth week), from medical records
Measured: 5-6 months
Number of infants with retinopathy of prematurity needing treatment
Pilot clinical data on retinopathy of prematurity needing treatment, from medical records
Measured: 5-6 months
Patent ductus arteriosus needing a closure procedure
Pilot clinical data on number of infants with patent ductus arteriosus needing a closure procedure, from medical records
Measured: 5-6 months
24-month follow-up
Neurosensory/developmental progress at 24 months corrected gestational age, which will consist principally of 2 validated parent-filled questionnaires:
- Ages and Stages Questionnaire-3 (ASQ)
- Child Behavior Checklist
- A single-question parent report of whether there has been a physician diagnosis of cerebral palsy.
Measured: 18-30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start1 Mar 2021
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot double-blind randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah McDonald, McMaster University
- 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
- NCT04494529
- Sponsor's protocol ID
- SNACS Pilot Trial
- Acronym
- SNACS Pilot
- Status last verified
- Aug 2023
- First submitted
- 16 Jul 2020
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Antenatal Corticosteroids (SNACS) Pilot Randomized Control Trial for Women at Risk of Preterm Birth
- ClinicalTrials.gov ID
- NCT04494529
- Acronym / sponsor ID
- SNACS Pilot / SNACS Pilot Trial
- Conditions
- Preterm Birth, Complication of Prematurity, Obstetric Labor, Premature, Obstetric Labor Complications, Pregnancy Complications
- Keywords
- Premature birth, Preterm birth, Obstetric labor, Betamethasone Valerate, Betamethasone-17,21-dipropionate, Betamethasone benzoate; Betamethasone sodium phosphate, Anti-Inflammatory Agents, Glucocorticoids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 31 Jul 2020 (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, such as respiratory distress syndrome, in preterm infants.
Standard of care for women at risk of preterm birth includes 2 doses of 12 mg betamethasone (for a total of 24 mg) to accelerate fetal lung maturity.
We plan to conduct a pilot clinical trial to determine the feasibility of a trial comparing half the usual dose (total 12 mg) of betamethasone to the standard double dose (total 24 mg) of betamethasone.
The results of this pilot will be combined with the full-scale RCT (NCT05114096) for which we have received funding from the Canadian Institutes of Health Research (CIHR).
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.
Standard of care for women at risk of preterm birth includes 2 doses of 12 mg betamethasone (for a total of 24 mg) to accelerate fetal lung maturity. There are no published clinical trial data on the benefits or risks of a single dose of antenatal corticosteroid vs. standard double doses.
Pilot trials are now viewed as an "almost essential prerequisite" to large, expensive, full scale studies. Thus, we plan to conduct a pilot clinical trial to determine the feasibility of a trial comparing half the usual dose (12 mg of betamethasone + placebo) to the standard double dose (12 mg + 12 mg of betamethasone), as well as the feasibility of the study protocol. Secondary outcomes will include process outcomes and pilot clinical outcomes, that will be combined with the full-scale RCT for which we have received funding from CIHR.
We plan to conduct a 24-month corrected gestational age follow-up, which will consist principally of 2 validated parent-filled questionnaires:
- Ages and Stages Questionnaire-3 (ASQ)
- Child Behavior Checklist
- A single question parent report of whether there has been a physician diagnosis of cerebral palsy. (recommended by our parent partners)
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
- Pilot double-blind randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Single-Dose (12 mg betamethasone + placebo) | Placebo comparator | Drug: 12 mg betamethasone + placeboThe standard course of betamethasone consists of 2 intramuscular injections of 12 mg betamethasone 24 hours apart for a total dose of 24 mg. Before enrolment and randomization in the SNACS trial, all women will have received a first 12 mg injection of betamethasone according to local hospital protocols. After this first injection, randomization is performed. Participants randomized to the experimental "Single-Dose" arm will receive a similar appearing placebo injection instead of the standard 2nd dose of 12 mg of betamethasone (i.e. they will receive the experimental single-dose regimen, total 12 mg of betamethasone only from the first injection). |
| Double-Dose (12 mg betamethasone + 12 mg betamethasone) | Active comparator | Drug: 24 mg betamethasoneThe standard course of betamethasone consists of 2 intramuscular injections of 12 mg betamethasone 24 hours apart for a total dose of 24 mg. Before enrolment and randomization in the SNACS trial, all women will have received a first 12 mg injection of betamethasone according to local hospital protocols. After this first injection, randomization is performed. Participants randomized to the "Double-Dose" arm will receive the standard 2nd dose of 12 mg of betamethasone injected intramuscularly (i.e. they will receive the standard double-dose regimen, total 24 mg of betamethasone). |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Pregnant women at risk of preterm birth with a singleton or twins between =>22+0/7 and <=34+6/7 weeks' gestation
- Pregnant with either singletons or twins
- Has already received the first dose of 12 mg intramuscular betamethasone within the past 24 hours
- All fetuses are alive and without compromise as per ultrasound or fetal heart monitor
- Is capable of giving informed, written consent in English
Key exclusion criteria (6 listed)
- Any contraindications to receiving corticosteroids
- Requires chronic doses of corticosteroids secondary to a medical condition (e.g. systemic lupus erythematosus, severe asthma, congenital adrenal hyperplasia, etc.)
- Received any prior doses of antenatal corticosteroids except for the 1st dose of 12 mg intramuscular betamethasone
- Had any previous participation in this trial
- Pregnant with a fetus with severe congenital anomaly (e.g. anencephaly, transposition of the great arteries, etc.) or major chromosomal abnormalities (e.g. Trisomy 18, Trisomy 21, etc.)
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 |
|---|---|---|
| 12 mg betamethasone + placeboAfter the first intramuscular injection of 12 mg of betamethasone, participants randomized to the "Placebo Comparator" group will receive 1 intramuscular injection of placebo. | Drug | Single-Dose (12 mg betamethasone + placebo) |
| 24 mg betamethasoneAfter the first intramuscular injection of 12 mg of betamethasone, participants randomized to the "Active Comparator" group will receive the standard 2nd intramuscular injection of 12 mg of betamethasone. | Drug | Double-Dose (12 mg betamethasone + 12 mg betamethasone) |
Primary outcome
Feasibility of conducting a full-scale trial
Time frame: 5-6 months
Feasibility of conducting a full-scale trial will be defined as => 50% recruitment of approached participants
Feasibility of the study protocol
Time frame: 5-6 months
Feasibility of the study intervention will be defined as => 98% compliance with the protocol
18 secondary outcomes
Process outcomes
Time frame: 5-6 months
Neonatal mortality rates
Time frame: 5-6 months
Respiratory morbidity rates
Time frame: 5-6 months
Severe intraventricular haemorrhage rates
Time frame: 5-6 months
Rates of severe bowel problems due to necrotizing enterocolitis
Time frame: 5-6 months
Duration of mechanical ventilation requiring an endotracheal tube
Time frame: 5-6 months
Need for supplemental oxygen and duration
Time frame: 5-6 months
Late respiratory morbidity (i.e. bronchopulmonary dysplasia) rates
Time frame: 5-6 months
Early neonatal sepsis rates
Time frame: 5-6 months
Severe late brain injury (periventricular leukomalacia) rates
Time frame: 5-6 months
Intrauterine fetal demise rates
Time frame: 5-6 months
Duration of ventilatory support not requiring an endotracheal tube
Time frame: 5-6 months
Rates of hypotension < 48 hours of life requiring treatment with hydrocortisone or inotropic medications
Time frame: 5-6 months
Length of stay in neonatal intensive care unit
Time frame: 5-6 months
Anthropometry composite (<10% of expected weight, length, or head circumference for birth week)
Time frame: 5-6 months
Number of infants with retinopathy of prematurity needing treatment
Time frame: 5-6 months
Patent ductus arteriosus needing a closure procedure
Time frame: 5-6 months
24-month follow-up
Time frame: 18-30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Sarah D McDonald, MD, MSc, FRCSC principal investigator
McMaster University
Kellie Murphy, MD, MSc, FRCSC principal investigator
University of Toronto
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 24 mg betamethasone in people with Preterm Birth and Complication of Prematurity, run by McMaster University 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 5 inclusion and 6 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 23 Aug 2023. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of conducting a full-scale trial (time frame: 5-6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Aug 2023.