Timing of Late Preterm Corticosteroid Administration and Neonatal Hypoglycemia
Overview
- Phase
- Phase 4
- Intervention
- Betamethasone Sodium Phosphate
- Conditions
- Neonatal Hypoglycemia
- Sponsor
- University of Southern California
- Enrollment
- 210
- Locations
- 1
- Primary Endpoint
- Neonatal Glucose Concentration
- Last Updated
- 5 years ago
Overview
Brief Summary
This is a prospective randomized controlled trial investigating the timing of betamethasone administration in late preterm infants in relation to delivery and impact on neonatal hypoglycemia. Previous data has shown that neonatal hypoglycemia is increased in late preterm infants that were exposed to antenatal corticosteroids. The investigators hypothesize that the timing of steroid administration may impact the development of neonatal hypoglycemia.
Detailed Description
The use of antenatal corticosteroids for women at risk for preterm delivery has become widely adopted as standard of care. The American College of Obstetrics and Gynecologists (ACOG) officially recommends the use of corticosteroids for pregnant women between 24 and 34 weeks of gestation at risk of delivery within 7 days. Since publication of the ALPS trial, the Society of Maternal Fetal Medicine (SMFM) published guidelines supporting the use of late preterm steroids for singleton pregnancies between 34 weeks 0 days and 36 weeks 6 days who are at high risk of preterm birth within 7 days. A secondary finding of the ALPS trial included the observation that the administration of antenatal betamethasone significantly increased the rate of neonatal hypoglycemia; the authors emphasized that while the long-term risks associated with neonatal hypoglycemia are not fully known, significant hypoglycemia is associated with poor neurodevelopmental outcome. The optimal interval for administering late preterm steroids before delivery to minimize the risks of hypoglycemia while maximizing the benefits of fetal lung maturity has not been identified. The proposed research study will further investigate this question by randomizing patients to receive late preterm corticosteroids 2 days before delivery versus 7 days before delivery in order to determine if the rates and severity of neonatal hypoglycemia are different.
Investigators
Elizabeth Sasso
Assistant Professor of Obstetrics & Gynecology
University of Southern California
Eligibility Criteria
Inclusion Criteria
- •Singleton pregnancy
- •Gestational age 34 0/7 weeks to 36 5/7 weeks
- •Planned delivery in late preterm period
Exclusion Criteria
- •Prior course of betamethasone during pregnancy
- •Twin gestation
- •Fetal demise
- •Major fetal anomaly
- •Maternal contraindication to betamethasone
- •Pregestational diabetes
- •Expected delivery within 12 hours of randomization
Arms & Interventions
Late Preterm Steroids 2 Days
Intervention: Betamethasone Sodium Phosphate
Late Preterm Steroids 7 Days
Intervention: Betamethasone Sodium Phosphate
Outcomes
Primary Outcomes
Neonatal Glucose Concentration
Time Frame: Delivery to 72 hours of life
Glucose reported in mg/dL; Hypoglycemia defined as concentration \< 40 mg/dL
Secondary Outcomes
- Stillbirth(From administration of the intervention (betamethasone) to delivery)
- Neonatal death(Delivery to 30 days of life)
- Respiratory distress syndrome (RDS)(Delivery to 72 hours of life)
- Transient Tachypnea of the Newborn(Delivery to 72 hours of life)
- Length of Hospital Stay(Delivery to discharge from hospital)
- Use of CPAP or High Flow Nasal Cannula(Delivery to 72 hours of life)
- Need for supplemental oxygen(Delivery to 72 hours of life)
- Use of ECMO(Delivery to 72 hours of life)
- Neonatal pneumonia(Delivery to 72 hours of life)
- Need for surfactant administration(Delivery to 72 hours of life)
- Use of mechanical ventilation(Delivery to 72 hours of life)