Late Preterm Corticosteroids and Neonatal Hypoglycemia

University of Southern California

Status and phase: Not yet enrolling; Phase 4

Conditions: Prematurity; Neonatal Hypoglycemia

Treatments: Drug: Betamethasone Sodium Phosphate

Study type: Interventional

Funder types: Other

Identifiers

NCT04869709

APP-21-01310

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

Late Preterm Steroids 2 Days

Active Comparator group

Treatment:

Drug: Betamethasone Sodium Phosphate

Late Preterm Steroids 7 Days

Active Comparator group

Treatment:

Drug: Betamethasone Sodium Phosphate