Low Dose Antenatal Corticosteroids for Late Preterm Delivery

Condition(s) studied

Investigational drug(s) / intervention(s)

we will use reduced dose of acceptable corticosteroids treatment for preterm birth: the two different group will differ in the doses of corticosteroids

Study summary

This is a study proposal for a clinical trial to evaluate the effectiveness of a reduced dose of antenatal betamethasone (a steroid medication) in preventing respiratory problems in late preterm infants (born between 34 and 36 weeks of gestation). The study will be conducted in medical centers in Israel and will involve women who are at high risk for delivering a late preterm infant. The participants will be randomly assigned to receive either a full dose (12 mg) or a quarter dose (3 mg) of betamethasone, administered 24 hours apart. The main outcome measure of the study will be the incidence of respiratory problems or neonatal death within 72 hours of delivery in the two groups. The study is designed to determine if the reduced dose of betamethasone is non-inferior (i.e., not significantly worse) than the full dose in preventing respiratory problems in late preterm infants.

Eligibility

Primary outcome measure(s)

• Respiratory morbidity — first 72 hours after birth
  1. Use of continuous positive airway pressure (CPAP) or high-flow nasal cannula for ≥2 continuous hr in the first 72 hours 2. Fraction of inspired oxygen of ≥0.30 for ≥4 continuous hr in the first 72 hours 3. Mechanical ventilation in the firdt 72 hours yes/no 4. extracorporeal membrane oxygenation (ECMO) yes/no 5. TTN: transient tachypnea of newborn yes/no

Trial sites (16)

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