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: 1. Ages and Stages Questionnaire-3 (ASQ) 2. Child Behavior Checklist 3. A single question parent report of whether there has been a physician diagnosis of cerebral palsy. (recommended by our parent partners)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
30
After the first intramuscular injection of 12 mg of betamethasone, participants randomized to the "Placebo Comparator" group will receive 1 intramuscular injection of placebo.
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.
McMaster University Medical Centre
Hamilton, Ontario, Canada
Feasibility of conducting a full-scale trial
Feasibility of conducting a full-scale trial will be defined as =\> 50% recruitment of approached participants
Time frame: 5-6 months
Feasibility of the study protocol
Feasibility of the study intervention will be defined as =\> 98% compliance with the protocol
Time frame: 5-6 months
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
Time frame: 5-6 months
Neonatal mortality rates
Pilot clinical data on neonatal mortality, from medical records
Time frame: 5-6 months
Respiratory morbidity rates
Pilot clinical data on respiratory morbidity, from medical records
Time frame: 5-6 months
Severe intraventricular haemorrhage rates
Pilot clinical data on severe intraventricular haemorrhage, from medical records
Time frame: 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
Time frame: 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
Time frame: 5-6 months
Need for supplemental oxygen and duration
Pilot clinical data on need for supplemental oxygen and duration, from medical records
Time frame: 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
Time frame: 5-6 months
Early neonatal sepsis rates
Pilot clinical data on early neonatal sepsis, from medical records
Time frame: 5-6 months
Severe late brain injury (periventricular leukomalacia) rates
Pilot clinical data on severe late brain injury (periventricular leukomalacia), from medical records
Time frame: 5-6 months
Intrauterine fetal demise rates
Pilot clinical data on intrauterine fetal demise, from medical records
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 5-6 months
Number of infants with retinopathy of prematurity needing treatment
Pilot clinical data on retinopathy of prematurity needing treatment, from medical records
Time frame: 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
Time frame: 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: 1. Ages and Stages Questionnaire-3 (ASQ) 2. Child Behavior Checklist 3. A single-question parent report of whether there has been a physician diagnosis of cerebral palsy.
Time frame: 18-30 months
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