Neonatal Hypoglycemia, Prematurity
Conditions
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.
Interventions
Betamethasone Sodium Phosphate 12mg IM q24h for 2 doses
Sponsors
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal Glucose Concentration | Delivery to 72 hours of life | Glucose reported in mg/dL; Hypoglycemia defined as concentration \< 40 mg/dL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use of ECMO | Delivery to 72 hours of life | Drop in oxygen saturation requiring use of ECMO (extracorporeal membrane oxygenation) |
| 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 |
| Need for surfactant administration | Delivery to 72 hours of life | Need for administration of exogenous surfactant in the setting of neonatal respiratory distress |
| 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. |
| 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 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Necrotizing Entercolitis | Delivery to 72 hours of life | When systemic, radiographic, and abdominal signs lead to a modified Bell stage 2 or 3 |
| Intraventricular Hemorrhage Grade 3 or 4 (Severe IVH) | Delivery to 72 hours of life | Defined when the extent of brain injury includes a hemorrhage that occupies more than 50% of the lateral ventricle volume |
| Feeding Difficulty | Delivery to 72 hours of life | inability to take all feeds by mouth, requiring gavage feeds or intravenous supplementation at least once. |
| Neonatal Hypothermia | Delivery to 72 hours of life | Defined as rectal temperature below 36 degrees Celsius |
| Need for resuscitation at birth | Within 30 minutes of delivery | Any intervention in the first 30 minutes, excluding blow-by oxygen |
Countries
United States
Contacts
Primary ContactElizabeth Sasso
Backup ContactGenevieve Mazza
Outcome results
None listed