Late Preterm Corticosteroids and Neonatal Hypoglycemia
- Registration Number
- NCT04869709
- Lead Sponsor
- University of Southern California
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 210
- Singleton pregnancy
- Gestational age 34 0/7 weeks to 36 5/7 weeks
- Planned delivery in late preterm period
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Late Preterm Steroids 7 Days Betamethasone Sodium Phosphate - Late Preterm Steroids 2 Days Betamethasone Sodium Phosphate -
- Primary Outcome Measures
Name Time Method Neonatal Glucose Concentration Delivery to 72 hours of life Glucose reported in mg/dL; Hypoglycemia defined as concentration \< 40 mg/dL
- Secondary Outcome Measures
Name Time Method Use of mechanical ventilation Delivery to 72 hours of life Drop in oxygen saturation and/or inability to maintain an airway requiring use of mechanical ventilation
Stillbirth From administration of the intervention (betamethasone) to delivery Incidence of intrauterine fetal demise at any point after administration of the intervention (betamethasone) and before delivery
Neonatal death Delivery to 30 days of life Death of fetus after delivery
Respiratory distress syndrome (RDS) Delivery to 72 hours of life Defined as the presence of clinical signs of respiratory distress (ie: tachypnea, retractions, flaring, grunting, cyanosis) with a requirement of supplemental oxygen with a fraction of inspired oxygen of more than 0.21 and a chest radiograph showing hypoaeration and reticulogranular infiltrates
Transient Tachypnea of the Newborn Delivery to 72 hours of life Defined when tachypnea (Respiratory Rate \>60 breaths per minute) occurs in the absence of chest radiography or a radiograph that was normal and resolved within 72 hours
Length of Hospital Stay Delivery to discharge from hospital Days in hospital from date of delivery until date of discharge
Use of CPAP or High Flow Nasal Cannula Delivery to 72 hours of life Drop in oxygen saturation requiring use of CPAP or high flow nasal cannula for at least 12 continuous hours
Need for supplemental oxygen Delivery to 72 hours of life Drop in oxygen saturation requiring use of supplemental oxygen with a fraction of inspired oxygen (FiO2) of at least 0.30 for at least 24 continuous hours
Use of ECMO Delivery to 72 hours of life Drop in oxygen saturation requiring use of ECMO (extracorporeal membrane oxygenation)
Neonatal pneumonia Delivery to 72 hours of life Defined when a combination of clinical, microbiologic, and/or radiographic findings suggest primary pulmonary infection as a cause of respiratory distress, fevers, increasing white blood cell count, need for antibiotics, and/or sepsis.
Need for surfactant administration Delivery to 72 hours of life Need for administration of exogenous surfactant in the setting of neonatal respiratory distress
Trial Locations
- Locations (1)
LAC+USC Medical Center
🇺🇸Los Angeles, California, United States