Antenatal corticosteroids (ACS) reduce the risks of neonatal death and morbidities in preterm infants, such as respiratory distress syndrome.
The standard of care for pregnant people at risk of preterm birth includes 2 doses of Celestone (for a total of 24 mg in Canada, or 22.8 mg in Australia) to accelerate fetal lung maturity.
The investigators plan to conduct a randomized controlled trial to determine whether half the usual dose (12 mg in Canada, or 11.4 mg in Australia) of Celestone is non-inferior to the standard double doses.
Pregnant people, aged 18 to 55 years old, at risk of preterm birth with a singleton or twins between 22 weeks and 0 days and <34 weeks and 6 days gestation who have received only a single dose of Celestone within 24 hours
Capable of giving informed, written consent.
Contraindication to corticosteroids
Systemic corticosteroids for medical conditions during the pregnancy (e.g. lupus, severe asthma, Covid, etc).
Previous participation in this trial (in a previous pregnancy)
Known severe/life-threatening fetal or pregnant patient condition (e.g. fetal congenital/chromosomal abnormality)
Parallel
Celestone + placebo
DrugAfter the first intramuscular injection of Celestone, participants randomized to the "Placebo Comparator" group will receive 1 intramuscular injection of placebo.
Celestone + Celestone
DrugAfter the first intramuscular injection of Celestone, participants randomized to the "Active Comparator" group will receive 1 intramuscular injection of Celestone.
Perinatal Mortality or Substantial Neonatal Morbidity
Fetal death post-randomization or in hospital neonatal death OR =\> 1 of respiratory morbidity (requiring surfactant \<=48 hrs of life), severe intraventricular hemorrhage (distending/beyond the ventricles, i.e. Grade 3 or 4), or severe bowel problem (necrotizing enterocolitis, Stage 2 or 3)
Death or neurosensory/developmental impairment at 24 months
Death or neurosensory/developmental impairment at 24 months (+/- 6 months; accounting for gestation at birth), mood (anxiety/depression), behavior (aggression), etc as assessed by: 1. Ages and Stages Questionnaire-3 (ASQ) 2. Child Behavior Checklist: 4 subscales 3. Physician diagnosis of cerebral palsy (parent report).
Number of babies who received intubation and duration of invasive mechanical ventilation
Number of babies who received intubation and duration of invasive mechanical ventilation
Number of babies who received, and duration of, supplemental oxygen (after resuscitation) and other ventilatory support
Number of babies who received, and duration of, supplemental oxygen (after resuscitation) and other ventilatory support
Number of babies with respiratory distress after the initial resuscitation/stabilization and main cause
Number of babies with respiratory distress after the initial resuscitation/stabilization and main cause (such as respiratory distress syndrome, pneumothorax/pneumomediastinum, pneumonia, transient tachypnea of the newborn, meconium aspiration syndrome, persistent pulmonary hypertension of the newborn)
Number of babies with Respiratory distress after the initial resuscitation/stabilization and main cause
Respiratory distress after the initial resuscitation/stabilization and main cause (such as respiratory distress syndrome, pneumothorax/pneumomediastinum, pneumonia, transient tachypnea of the newborn, meconium aspiration syndrome, persistent pulmonary hypertension of the newborn),
Click on the lead sponsor to view all of their trials.
McMaster University
Lead sponsor
Hamilton Health Sciences Corporation
Collaborator
Sunnybrook Research Institute
Collaborator
Women's and Children's Hospital, Australia
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
Medical Research Future Fund
Collaborator
University of Adelaide
Collaborator
