Single Dose Antenatal Corticosteroids (SNACS) for Women at Risk of Preterm Birth

Preterm Birth Clinical Trial

— SNACS Pilot  

Official title:

Single Dose Antenatal Corticosteroids (SNACS) Pilot Randomized Control Trial for Women at Risk of Preterm Birth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04494529
• Other study ID #: SNACS Pilot Trial
• Status: Completed
• Phase: Phase 3
• Start date: March 1, 2021
• Est. completion date: August 31, 2021

Study information

• Verified date: August 2023
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Pregnant women at risk of preterm birth with a singleton or twins between =>22+0/7 and <=34+6/7 weeks' gestation

2. Pregnant with either singletons or twins

3. Has already received the first dose of 12 mg intramuscular betamethasone within the past 24 hours

4. All fetuses are alive and without compromise as per ultrasound or fetal heart monitor

5. Is capable of giving informed, written consent in English

Exclusion Criteria:

1. Any contraindications to receiving corticosteroids

2. Requires chronic doses of corticosteroids secondary to a medical condition (e.g. systemic lupus erythematosus, severe asthma, congenital adrenal hyperplasia, etc.)

3. Received any prior doses of antenatal corticosteroids except for the 1st dose of 12 mg intramuscular betamethasone

4. Had any previous participation in this trial

5. Pregnant with a fetus with severe congenital anomaly (e.g. anencephaly, transposition of the great arteries, etc.) or major chromosomal abnormalities (e.g. Trisomy 18, Trisomy 21, etc.)

6. Pregnant with monoamniotic/monochorionic (Mono/Mono) twins

Related Conditions & MeSH terms

• Complication of Prematurity
• Obstetric Labor Complications
• Obstetric Labor, Premature
• Pregnancy Complications
• Premature Birth
• Preterm Birth

Intervention

Drug:
• 12 mg betamethasone + placebo
After the first intramuscular injection of 12 mg of betamethasone, participants randomized to the "Placebo Comparator" group will receive 1 intramuscular injection of placebo.
• 24 mg betamethasone
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.

Locations

Country	Name	City	State
Canada	McMaster University Medical Centre	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Feasibility of the study protocol	Feasibility of the study intervention will be defined as => 98% compliance with the protocol	5-6 months
Secondary	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
Secondary	Neonatal mortality rates	Pilot clinical data on neonatal mortality, from medical records	5-6 months
Secondary	Respiratory morbidity rates	Pilot clinical data on respiratory morbidity, from medical records	5-6 months
Secondary	Severe intraventricular haemorrhage rates	Pilot clinical data on severe intraventricular haemorrhage, from medical records	5-6 months
Secondary	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
Secondary	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
Secondary	Need for supplemental oxygen and duration	Pilot clinical data on need for supplemental oxygen and duration, from medical records	5-6 months
Secondary	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
Secondary	Early neonatal sepsis rates	Pilot clinical data on early neonatal sepsis, from medical records	5-6 months
Secondary	Severe late brain injury (periventricular leukomalacia) rates	Pilot clinical data on severe late brain injury (periventricular leukomalacia), from medical records	5-6 months
Secondary	Intrauterine fetal demise rates	Pilot clinical data on intrauterine fetal demise, from medical records	5-6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of infants with retinopathy of prematurity needing treatment	Pilot clinical data on retinopathy of prematurity needing treatment, from medical records	5-6 months
Secondary	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
Secondary	24-month follow-up	Neurosensory/developmental progress at 24 months corrected gestational age, which will consist principally of 2 validated parent-filled questionnaires: Ages and Stages Questionnaire-3 (ASQ); Child Behavior Checklist; A single-question parent report of whether there has been a physician diagnosis of cerebral palsy.	18-30 months