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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
210
Betamethasone Sodium Phosphate 12mg IM q24h for 2 doses
LAC+USC Medical Center
Los Angeles, California, United States
Neonatal Glucose Concentration
Glucose reported in mg/dL; Hypoglycemia defined as concentration \< 40 mg/dL
Time frame: Delivery to 72 hours of life
Length of Hospital Stay
Days in hospital from date of delivery until date of discharge
Time frame: Delivery to discharge from hospital
Use of CPAP or High Flow Nasal Cannula
Drop in oxygen saturation requiring use of CPAP or high flow nasal cannula for at least 12 continuous hours
Time frame: Delivery to 72 hours of life
Need for supplemental oxygen
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
Time frame: Delivery to 72 hours of life
Use of ECMO
Drop in oxygen saturation requiring use of ECMO (extracorporeal membrane oxygenation)
Time frame: Delivery to 72 hours of life
Use of mechanical ventilation
Drop in oxygen saturation and/or inability to maintain an airway requiring use of mechanical ventilation
Time frame: Delivery to 72 hours of life
Stillbirth
Incidence of intrauterine fetal demise at any point after administration of the intervention (betamethasone) and before delivery
Time frame: From administration of the intervention (betamethasone) to delivery
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Neonatal death
Death of fetus after delivery
Time frame: Delivery to 30 days of life
Respiratory distress syndrome (RDS)
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
Time frame: Delivery to 72 hours of life
Transient Tachypnea of the Newborn
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
Time frame: Delivery to 72 hours of life
Need for surfactant administration
Need for administration of exogenous surfactant in the setting of neonatal respiratory distress
Time frame: Delivery to 72 hours of life
Neonatal pneumonia
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.
Time frame: Delivery to 72 hours of life