Back to resultsSingle Dose Antenatal Corticosteroids (SNACS) for Women at Risk of Preterm Birth (SNACS Pilot)
Primary Purpose
Preterm Birth, Complication of Prematurity, Obstetric Labor, Premature
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
12 mg betamethasone + placebo
24 mg betamethasone
Sponsored by
About this trial
This is an interventional other trial for Preterm Birth focused on measuring 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
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- McMaster University Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Single-Dose (12 mg betamethasone + placebo)
Double-Dose (12 mg betamethasone + 12 mg betamethasone)
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
Feasibility of conducting a full-scale trial
Feasibility of conducting a full-scale trial will be defined as => 50% recruitment of approached participants
Feasibility of the study protocol
Feasibility of the study intervention will be defined as => 98% compliance with the protocol
Secondary Outcome Measures
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
Neonatal mortality rates
Pilot clinical data on neonatal mortality, from medical records
Respiratory morbidity rates
Pilot clinical data on respiratory morbidity, from medical records
Severe intraventricular haemorrhage rates
Pilot clinical data on severe intraventricular haemorrhage, from medical records
Rates of severe bowel problems due to necrotizing enterocolitis
Pilot clinical data on severe bowel problems due to necrotizing enterocolitis, from medical records
Duration of mechanical ventilation requiring an endotracheal tube
Pilot clinical data on duration of mechanical ventilation requiring an endotracheal tube, from medical records
Need for supplemental oxygen and duration
Pilot clinical data on need for supplemental oxygen and duration, from medical records
Late respiratory morbidity (i.e. bronchopulmonary dysplasia) rates
Pilot clinical data on late respiratory morbidity (i.e. bronchopulmonary dysplasia), from medical records
Early neonatal sepsis rates
Pilot clinical data on early neonatal sepsis, from medical records
Severe late brain injury (periventricular leukomalacia) rates
Pilot clinical data on severe late brain injury (periventricular leukomalacia), from medical records
Intrauterine fetal demise rates
Pilot clinical data on intrauterine fetal demise, from medical records
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
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
Length of stay in neonatal intensive care unit
Pilot clinical data on length of stay in neonatal intensive care unit, from medical records
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
Number of infants with retinopathy of prematurity needing treatment
Pilot clinical data on retinopathy of prematurity needing treatment, from medical records
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04494529
Brief Title
Single Dose Antenatal Corticosteroids (SNACS) for Women at Risk of Preterm Birth
Acronym
SNACS Pilot
Official Title
Single Dose Antenatal Corticosteroids (SNACS) Pilot Randomized Control Trial for Women at Risk of Preterm Birth
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, Hormones, Hormone Substitutes, Hormone Antagonists, Physiological Effect of Drugs, Anti-Asthmatic Agents, Respiratory System Agents
7. Study Design
Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Pilot double-blind randomized controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single-Dose (12 mg betamethasone + placebo)
Arm Type
Placebo Comparator
Arm Description
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).
Arm Title
Double-Dose (12 mg betamethasone + 12 mg betamethasone)
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
12 mg betamethasone + placebo
Intervention Description
After the first intramuscular injection of 12 mg of betamethasone, participants randomized to the "Placebo Comparator" group will receive 1 intramuscular injection of placebo.
Intervention Type
Drug
Intervention Name(s)
24 mg betamethasone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of conducting a full-scale trial
Description
Feasibility of conducting a full-scale trial will be defined as => 50% recruitment of approached participants
Time Frame
5-6 months
Title
Feasibility of the study protocol
Description
Feasibility of the study intervention will be defined as => 98% compliance with the protocol
Time Frame
5-6 months
Secondary Outcome Measure Information:
Title
Process outcomes
Description
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
Time Frame
5-6 months
Title
Neonatal mortality rates
Description
Pilot clinical data on neonatal mortality, from medical records
Time Frame
5-6 months
Title
Respiratory morbidity rates
Description
Pilot clinical data on respiratory morbidity, from medical records
Time Frame
5-6 months
Title
Severe intraventricular haemorrhage rates
Description
Pilot clinical data on severe intraventricular haemorrhage, from medical records
Time Frame
5-6 months
Title
Rates of severe bowel problems due to necrotizing enterocolitis
Description
Pilot clinical data on severe bowel problems due to necrotizing enterocolitis, from medical records
Time Frame
5-6 months
Title
Duration of mechanical ventilation requiring an endotracheal tube
Description
Pilot clinical data on duration of mechanical ventilation requiring an endotracheal tube, from medical records
Time Frame
5-6 months
Title
Need for supplemental oxygen and duration
Description
Pilot clinical data on need for supplemental oxygen and duration, from medical records
Time Frame
5-6 months
Title
Late respiratory morbidity (i.e. bronchopulmonary dysplasia) rates
Description
Pilot clinical data on late respiratory morbidity (i.e. bronchopulmonary dysplasia), from medical records
Time Frame
5-6 months
Title
Early neonatal sepsis rates
Description
Pilot clinical data on early neonatal sepsis, from medical records
Time Frame
5-6 months
Title
Severe late brain injury (periventricular leukomalacia) rates
Description
Pilot clinical data on severe late brain injury (periventricular leukomalacia), from medical records
Time Frame
5-6 months
Title
Intrauterine fetal demise rates
Description
Pilot clinical data on intrauterine fetal demise, from medical records
Time Frame
5-6 months
Title
Duration of ventilatory support not requiring an endotracheal tube
Description
Pilot clinical data on duration of ventilatory support not requiring an endotracheal tube, from medical records
Time Frame
5-6 months
Title
Rates of hypotension < 48 hours of life requiring treatment with hydrocortisone or inotropic medications
Description
Pilot clinical data on hypotension < 48 hours of life requiring treatment with hydrocortisone or inotropic medications, from medical records
Time Frame
5-6 months
Title
Length of stay in neonatal intensive care unit
Description
Pilot clinical data on length of stay in neonatal intensive care unit, from medical records
Time Frame
5-6 months
Title
Anthropometry composite (<10% of expected weight, length, or head circumference for birth week)
Description
Pilot clinical data on anthropometry (<10% of expected weight, length, or head circumference for birth week), from medical records
Time Frame
5-6 months
Title
Number of infants with retinopathy of prematurity needing treatment
Description
Pilot clinical data on retinopathy of prematurity needing treatment, from medical records
Time Frame
5-6 months
Title
Patent ductus arteriosus needing a closure procedure
Description
Pilot clinical data on number of infants with patent ductus arteriosus needing a closure procedure, from medical records
Time Frame
5-6 months
Title
24-month follow-up
Description
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.
Time Frame
18-30 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah D McDonald, MD, MSc, FRCSC
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kellie Murphy, MD, MSc, FRCSC
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University Medical Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N3Z5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Single Dose Antenatal Corticosteroids (SNACS) for Women at Risk of Preterm Birth
We'll reach out to this number within 24 hrs