Late Preterm Corticosteroids and Neonatal Hypoglycemia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Late Preterm Steroids 2 Days
|
Drug: Betamethasone Sodium Phosphate
Betamethasone Sodium Phosphate 12mg IM q24h for 2 doses
Other Names:
|
| Active Comparator: Late Preterm Steroids 7 Days
|
Drug: Betamethasone Sodium Phosphate
Betamethasone Sodium Phosphate 12mg IM q24h for 2 doses
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Neonatal Glucose Concentration [Delivery to 72 hours of life]
Glucose reported in mg/dL; Hypoglycemia defined as concentration < 40 mg/dL
Secondary Outcome Measures
- 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)
- 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
- 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.
Other Outcome Measures
- Need for resuscitation at birth [Within 30 minutes of delivery]
Any intervention in the first 30 minutes, excluding blow-by oxygen
- Neonatal Hypothermia [Delivery to 72 hours of life]
Defined as rectal temperature below 36 degrees Celsius
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | LAC+USC Medical Center | Los Angeles | California | United States | 90033 |
Sponsors and Collaborators
- University of Southern California
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Gyamfi-Bannerman C, Thom EA, Blackwell SC, Tita AT, Reddy UM, Saade GR, Rouse DJ, McKenna DS, Clark EA, Thorp JM Jr, Chien EK, Peaceman AM, Gibbs RS, Swamy GK, Norton ME, Casey BM, Caritis SN, Tolosa JE, Sorokin Y, VanDorsten JP, Jain L; NICHD Maternal-Fetal Medicine Units Network. Antenatal Betamethasone for Women at Risk for Late Preterm Delivery. N Engl J Med. 2016 Apr 7;374(14):1311-20. doi: 10.1056/NEJMoa1516783. Epub 2016 Feb 4.
- Kamath-Rayne BD, Rozance PJ, Goldenberg RL, Jobe AH. Antenatal corticosteroids beyond 34 weeks gestation: What do we do now? Am J Obstet Gynecol. 2016 Oct;215(4):423-30. doi: 10.1016/j.ajog.2016.06.023. Epub 2016 Jun 21. Review.
- Liggins GC, Howie RN. A controlled trial of antepartum glucocorticoid treatment for prevention of the respiratory distress syndrome in premature infants. Pediatrics. 1972 Oct;50(4):515-25.
- Practice Bulletin No. 159: Management of Preterm Labor. Obstet Gynecol. 2016 Jan;127(1):e29-e38. doi: 10.1097/AOG.0000000000001265. Review.
- Society for Maternal-Fetal Medicine (SMFM) Publications Committee. Implementation of the use of antenatal corticosteroids in the late preterm birth period in women at risk for preterm delivery. Am J Obstet Gynecol. 2016 Aug;215(2):B13-5. doi: 10.1016/j.ajog.2016.03.013. Epub 2016 Mar 15. Review. Erratum in: Am J Obstet Gynecol. 2017 Feb;216(2):180.
- Uquillas KR, Lee RH, Sardesai S, Chen E, Ihenacho U, Cortessis VK, Barton L. Neonatal hypoglycemia after initiation of late preterm antenatal corticosteroids. J Perinatol. 2020 Sep;40(9):1339-1348. doi: 10.1038/s41372-020-0589-1. Epub 2020 Feb 14.
- APP-21-01310