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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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 12 mg betamethasone + placebo | Drug | After the first intramuscular injection of 12 mg of betamethasone, participants randomized to the "Placebo Comparator" group will receive 1 intramuscular injection of placebo. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of conducting a full-scale trial | Feasibility of conducting a full-scale trial will be defined as => 50% recruitment of approached participants | 5-6 months |
| Feasibility of the study protocol | Feasibility of the study intervention will be defined as => 98% compliance with the protocol | 5-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 5-6 months |
| Neonatal mortality rates |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah D McDonald, MD, MSc, FRCSC | McMaster University | Principal Investigator |
| Kellie Murphy, MD, MSc, FRCSC | University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University Medical Centre | Hamilton | Ontario | L8N3Z5 | Canada |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D001623 | Betamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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Pilot double-blind randomized controlled trial
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| 24 mg betamethasone | Drug | 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. |
|
Pilot clinical data on neonatal mortality, from medical records
| 5-6 months |
| Respiratory morbidity rates | Pilot clinical data on respiratory morbidity, from medical records | 5-6 months |
| Severe intraventricular haemorrhage rates | Pilot clinical data on severe intraventricular haemorrhage, from medical records | 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 | 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 | 5-6 months |
| Need for supplemental oxygen and duration | Pilot clinical data on need for supplemental oxygen and duration, from medical records | 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 | 5-6 months |
| Early neonatal sepsis rates | Pilot clinical data on early neonatal sepsis, from medical records | 5-6 months |
| Severe late brain injury (periventricular leukomalacia) rates | Pilot clinical data on severe late brain injury (periventricular leukomalacia), from medical records | 5-6 months |
| Intrauterine fetal demise rates | Pilot clinical data on intrauterine fetal demise, from medical records | 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 | 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 | 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 | 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 | 5-6 months |
| Number of infants with retinopathy of prematurity needing treatment | Pilot clinical data on retinopathy of prematurity needing treatment, from medical records | 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 | 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:
| 18-30 months |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |