Preterm Birth Clinical Trial
— SNACSOfficial title:
Single Dose of Antenatal Corticosteroids (SNACS) Randomized Controlled Trial for Pregnancies at Risk of Preterm Delivery: To Keep Babies and Children Safe
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.
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 |
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 |
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 |
Australia, Canada,
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
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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