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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04494529




Registration number
NCT04494529
Ethics application status
Date submitted
16/07/2020
Date registered
31/07/2020
Date last updated
23/08/2023

Titles & IDs
Public title
Single Dose Antenatal Corticosteroids (SNACS) for Women at Risk of Preterm Birth
Scientific title
Single Dose Antenatal Corticosteroids (SNACS) Pilot Randomized Control Trial for Women at Risk of Preterm Birth
Secondary ID [1] 0 0
SNACS Pilot Trial
Universal Trial Number (UTN)
Trial acronym
SNACS Pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn
Reproductive Health and Childbirth 0 0 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 12 mg betamethasone + placebo
Treatment: Drugs - 24 mg betamethasone

Placebo Comparator: Single-Dose (12 mg betamethasone + placebo) - 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).

Active Comparator: Double-Dose (12 mg betamethasone + 12 mg betamethasone) - 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).


Treatment: Drugs: 12 mg betamethasone + placebo
After the first intramuscular injection of 12 mg of betamethasone, participants randomized to the "Placebo Comparator" group will receive 1 intramuscular injection of placebo.

Treatment: Drugs: 24 mg betamethasone
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Feasibility of conducting a full-scale trial
Timepoint [1] 0 0
5-6 months
Primary outcome [2] 0 0
Feasibility of the study protocol
Timepoint [2] 0 0
5-6 months
Secondary outcome [1] 0 0
Process outcomes
Timepoint [1] 0 0
5-6 months
Secondary outcome [2] 0 0
Neonatal mortality rates
Timepoint [2] 0 0
5-6 months
Secondary outcome [3] 0 0
Respiratory morbidity rates
Timepoint [3] 0 0
5-6 months
Secondary outcome [4] 0 0
Severe intraventricular haemorrhage rates
Timepoint [4] 0 0
5-6 months
Secondary outcome [5] 0 0
Rates of severe bowel problems due to necrotizing enterocolitis
Timepoint [5] 0 0
5-6 months
Secondary outcome [6] 0 0
Duration of mechanical ventilation requiring an endotracheal tube
Timepoint [6] 0 0
5-6 months
Secondary outcome [7] 0 0
Need for supplemental oxygen and duration
Timepoint [7] 0 0
5-6 months
Secondary outcome [8] 0 0
Late respiratory morbidity (i.e. bronchopulmonary dysplasia) rates
Timepoint [8] 0 0
5-6 months
Secondary outcome [9] 0 0
Early neonatal sepsis rates
Timepoint [9] 0 0
5-6 months
Secondary outcome [10] 0 0
Severe late brain injury (periventricular leukomalacia) rates
Timepoint [10] 0 0
5-6 months
Secondary outcome [11] 0 0
Intrauterine fetal demise rates
Timepoint [11] 0 0
5-6 months
Secondary outcome [12] 0 0
Duration of ventilatory support not requiring an endotracheal tube
Timepoint [12] 0 0
5-6 months
Secondary outcome [13] 0 0
Rates of hypotension < 48 hours of life requiring treatment with hydrocortisone or inotropic medications
Timepoint [13] 0 0
5-6 months
Secondary outcome [14] 0 0
Length of stay in neonatal intensive care unit
Timepoint [14] 0 0
5-6 months
Secondary outcome [15] 0 0
Anthropometry composite (<10% of expected weight, length, or head circumference for birth week)
Timepoint [15] 0 0
5-6 months
Secondary outcome [16] 0 0
Number of infants with retinopathy of prematurity needing treatment
Timepoint [16] 0 0
5-6 months
Secondary outcome [17] 0 0
Patent ductus arteriosus needing a closure procedure
Timepoint [17] 0 0
5-6 months
Secondary outcome [18] 0 0
24-month follow-up
Timepoint [18] 0 0
18-30 months

Eligibility
Key inclusion criteria
1. Pregnant women at risk of preterm birth with a singleton or twins between =>22+0/7 and <=34+6/7 weeks' gestation
2. Pregnant with either singletons or twins
3. Has already received the first dose of 12 mg intramuscular betamethasone within the past 24 hours
4. All fetuses are alive and without compromise as per ultrasound or fetal heart monitor
5. Is capable of giving informed, written consent in English
Minimum age
16 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any contraindications to receiving corticosteroids
2. Requires chronic doses of corticosteroids secondary to a medical condition (e.g. systemic lupus erythematosus, severe asthma, congenital adrenal hyperplasia, etc.)
3. Received any prior doses of antenatal corticosteroids except for the 1st dose of 12 mg intramuscular betamethasone
4. Had any previous participation in this trial
5. 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.)
6. Pregnant with monoamniotic/monochorionic (Mono/Mono) twins

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/08/2021
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Other
Name
McMaster University
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT04494529
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Sarah D McDonald, MD, MSc, FRCSC
Address 0 0
McMaster University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04494529