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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05114096
Other study ID # 3764
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date July 20, 2023
Est. completion date December 31, 2029

Study information

Verified date April 2024
Source McMaster University
Contact Sarah D McDonald, MD,MSc,FRCSC
Phone 905-525-9140
Email mcdonals@mcmaster.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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. The standard of care for pregnant people at risk of preterm birth includes 2 doses of Celestone to accelerate fetal lung maturity (total 24 mg in Canada, 22.8 mg in Australia). There are no published clinical trial data on the benefits or risks of a single dose of antenatal corticosteroid vs. standard double doses (Ninan et al JOGC 2020). Pregnant people at 22 weeks and 0 days to < 34 weeks and 6 days' gestation at risk of preterm birth with a singleton or twin gestation who have received the first dose of Celestone and consented to the trial will be randomized to receive approximately 24 hours later either an experimental placebo injection (of normal saline) or the standard double dose of Celestone to determine whether the intervention is non-inferior for the primary outcome of a composite of perinatal mortality or substantial morbidity. Please note: Based on Health Canada's' guidance the study phase is 'Other: Off-Label use'. However, on the clincaltrial.gov record, 'Phase 4' is selected as this is the most relevant phase and there is no option to select 'Other'. Please note: McMaster University, Canada is the Canadian Regulatory Sponsor and Overall Sponsor, and the University of Adelaide Australia is the Australian Sponsor.


Recruitment information / eligibility

Status Recruiting
Enrollment 3254
Est. completion date December 31, 2029
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: 1. 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 2. Capable of giving informed, written consent. Exclusion Criteria: 1. Contraindication to corticosteroids 2. Systemic corticosteroids for medical conditions during the pregnancy (e.g. lupus, severe asthma, Covid, etc). 3. Previous participation in this trial (in a previous pregnancy) 4. Known severe/life-threatening fetal or pregnant patient condition (e.g. fetal congenital/chromosomal abnormality) 5. Demise of one or more fetuses after 14 weeks and 0 days

Study Design


Intervention

Drug:
Celestone + placebo
After the first intramuscular injection of Celestone, participants randomized to the "Placebo Comparator" group will receive 1 intramuscular injection of placebo.
Celestone + Celestone
After the first intramuscular injection of Celestone, participants randomized to the "Active Comparator" group will receive 1 intramuscular injection of Celestone.

Locations

Country Name City State
Australia Moorabbin Hospital, Monash Health Clayton Victoria
Australia University of Melbourne; Mercy Hospital for Women Heidelberg Victoria
Australia Royal Brisbane & Women's Hospital Herston Queensland
Australia Royal Hobart Hospital Hobart Tasmania
Australia University of Queensland and Ipswich Hospital Ipswich Queensland
Australia John Hunter Hospital Newcastle New South Wales
Australia The University of Newcastle Newcastle New South Wales
Australia University of Adelaide; Women's & Children's Hospital North Adelaide South Australia
Australia The Royal Women's Hospital; University of Melbourne Parkville Victoria
Australia The Royal Hospital for Women Randwick New South Wales
Australia The University of Melbourne; Joan Kirner Women's & Children's Sunshine Hospital Saint Albans Victoria
Australia Mater Centre for Maternal Fetal Medicine South Brisbane Queensland
Australia The University of Queensland; Mater Research Institute/University of Queensland South Brisbane Queensland
Australia The University of New South Wales, St George Hospital Sydney New South Wales
Australia Royal Darwin Hospital Tiwi Northern Territory
Australia Townsville Hospital and Health Services Townsville Queensland
Australia University of Sydney; Westmead Institute for Maternal Fetal Medicine, Westmead Hospital Westmead New South Wales
Canada University of Calgary, Cumming School of Medicine Calgary Alberta
Canada Alberta Health Services; University of Alberta Edmonton Alberta
Canada Dr. Everett Chalmers Regional Hospital Fredericton New Brunswick
Canada Dalhousie University Halifax Nova Scotia
Canada McMaster University Hamilton Ontario
Canada Queen's University, Kingston General Hospital Health Sciences Centre Kingston Ontario
Canada Western University; London Health Sciences Centre, Victoria Hospital London Ontario
Canada The Moncton Hospital, Horizon Health Network Moncton New Brunswick
Canada McGill University, McGill University Health Center, Royal Victoria Hospital Montréal Quebec
Canada Sir Mortimer B. Davis Jewish General Hospital; McGill University Montréal Quebec
Canada The Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal Montréal Quebec
Canada Royal Columbian Hospital New Westminster British Columbia
Canada University of Ottawa; The Ottawa Hospital Ottawa Ontario
Canada Université Laval, Centre de recherche du CHU de Québec Québec City Quebec
Canada University of Saskatchewan, Regina General Hospital Saskatoon Saskatchewan
Canada (CIUSSS de l'Estrie-CHUS); Université de Sherbrooke Sherbrooke Quebec
Canada Memorial University, Eastern Health St. John's Newfoundland and Labrador
Canada Fraser Health, University of British Columbia; Jim Pattison Outpatient Care and Surgery Centre Surrey British Columbia
Canada Mount Sinai Hospital Toronto Ontario
Canada Sunnybrook Health Sciences Center Toronto Ontario
Canada University of British Columbia; BC Women's Hospital Vancouver British Columbia
Canada Victoria General Hospital Victoria British Columbia
Canada University of Manitoba, Health Sciences Centre Winnipeg Manitoba
Canada University of Manitoba; St. Boniface General Hospital Winnipeg Manitoba

Sponsors (7)

Lead Sponsor Collaborator
McMaster University Canadian Institutes of Health Research (CIHR), Hamilton Health Sciences Corporation, Medical Research Future Fund, Sunnybrook Research Institute, University of Adelaide, Women's and Children's Hospital, Australia

Countries where clinical trial is conducted

Australia,  Canada, 

References & Publications (1)

Ninan K, Morfaw F, Murphy KE, Beyene J, McDonald SD. Neonatal and Maternal Outcomes of Lower Versus Standard Doses of Antenatal Corticosteroids for Women at Risk of Preterm Delivery: A Systematic Review of Randomized Controlled Trials. J Obstet Gynaecol Can. 2021 Jan;43(1):74-81. doi: 10.1016/j.jogc.2020.02.127. Epub 2020 Mar 26. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Number of babies who received intubation and duration of invasive mechanical ventilation Number of babies who received intubation and duration of invasive mechanical ventilation approximately up to first 6 months of life
Other 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 approximately up to first 6 months of life
Other 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) approximately 1 month
Other 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), approximately at birth
Other Number of babies with hypoglycemia Number of babies with hypoglycemia (low plasma glucose < 2.6 mmol/L between 30 minutes and 48 hours of life) 48 hours
Other Number of babies with neonatal sepsis Number of babies with neonatal sepsis within 7 days of birth, defined as a positive (bacterial, viral or fungal): blood culture or cerebrospinal fluid culture (or gram stain) or urine culture by sterile collection. 7 days
Other Number of babies with severe retinopathy of prematurity needing treatment Number of babies with severe retinopathy of prematurity defined as requiring vascular endothelial growth factor (VEGF) or laser or cryotherapy per the local guidelines approximately first few months of life
Other Number of babies with patent ductus arteriosus (PDA) needing a closure procedure (surgery or device) Number of babies with patent ductus arteriosus (PDA) needing a closure procedure (surgery or device) up to 12 weeks after birth
Other Anthropometry at birth and at 24 months corrected age Weight (in grams), length (in centimeters), and head circumference (in centimeters) for birth week as ACS can impact growth at birth and at 24 months corrected age
Other Number of babies with severe late brain injury Periventricular leukomalacia [PVL], i.e. cystic changes in white matter or porencephalic cysts or white matter changes diagnosed by ultrasound or MRI. up to 20 weeks postnatal
Other Number of babies with chronic lung disease Late respiratory morbidity, bronchopulmonary dysplasia (BPD), defined as requiring respiratory support or supplemental oxygen > 36 completed weeks' corrected gestation. approximately up to first 6 months of life
Other Apgar score and cord blood pH Apgar score (at 1 and 5 min) and lowest cord blood pH, regardless of whether arterial or venous. approximately at birth
Other Length of stay in special care or an intensive care setting Length of stay in an intensive care setting such as the neonatal intensive care unit (NICU). approximately up to first 6 months of life
Other Use of postnatal corticosteroids Use of systemic (intravenous or oral) postnatal corticosteroids and type (e.g. hydrocortisone, dexamethasone). up to 20 weeks postnatal
Other Number of babies with longterm health care outcomes Number of babies with reported longterm health care outcomes after initial hospital, such as hospitalizations, and other health care use. approximately 5 -10 years
Other Number of babies with longterm education outcomes Number of babies with reported longterm education or non-health data outcomes, collected through database linkage where possible. approximately 5 -10 years
Other Number of participants with fetal death post-randomization or in hospital neonatal death OR => 1 of respiratory morbidity, severe intraventricular hemorrhage , or severe bowel problem 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) approximately 1 month
Primary 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) approximately 1 month
Secondary 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:
Ages and Stages Questionnaire-3 (ASQ)
Child Behavior Checklist: 4 subscales
Physician diagnosis of cerebral palsy (parent report).
approximately 24 months
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