Late Preterm Corticosteroids and Neonatal Hypoglycemia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Timing of Late Preterm Corticosteroid Administration and Neonatal Hypoglycemia

Conditions
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Prematurity, Neonatal Hypoglycemia

Intervention / Treatment
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* Drug: Betamethasone Sodium Phosphate


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Late Preterm Steroids 2 Days<br> | Drug: Betamethasone Sodium Phosphate<br>* Betamethasone Sodium Phosphate 12mg IM q24h for 2 doses<br>* Other names: Celestone;|
| Active Comparator: Late Preterm Steroids 7 Days<br> | Drug: Betamethasone Sodium Phosphate<br>* Betamethasone Sodium Phosphate 12mg IM q24h for 2 doses<br>* Other names: Celestone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal Glucose Concentration | Glucose reported in mg/dL; Hypoglycemia defined as concentration < 40 mg/dL | Delivery to 72 hours of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Hospital Stay | Days in hospital from date of delivery until date of discharge | 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 | 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 | Delivery to 72 hours of life | 
| Use of ECMO | Drop in oxygen saturation requiring use of ECMO (extracorporeal membrane oxygenation) | 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 | Delivery to 72 hours of life | 
| Stillbirth | Incidence of intrauterine fetal demise at any point after administration of the intervention (betamethasone) and before delivery | From administration of the intervention (betamethasone) to delivery | 
| Neonatal death | Death of fetus after delivery | 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 | 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 | Delivery to 72 hours of life | 
| Need for surfactant administration | Need for administration of exogenous surfactant in the setting of neonatal respiratory distress | 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. | Delivery to 72 hours of life |