Late Preterm Corticosteroids and Neonatal Hypoglycemia

Prematurity Clinical Trial

Official title:

Timing of Late Preterm Corticosteroid Administration and Neonatal Hypoglycemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04869709
• Other study ID #: APP-21-01310
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 2021
• Est. completion date: July 2024

Study information

• Verified date: April 2021
• Source: University of Southern California
• Contact: Elizabeth Sasso
• Phone: 3234093536
• Email: elizabeth.sasso[@]med.usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 210
• Est. completion date: July 2024
• Est. primary completion date: July 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoglycemia
• Neonatal Hypoglycemia
• Prematurity

Intervention

Drug:
• Betamethasone Sodium Phosphate
Betamethasone Sodium Phosphate 12mg IM q24h for 2 doses

Locations

Country	Name	City	State
United States	LAC+USC Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

Practice Bulletin No. 159: Management of Preterm Labor. Obstet Gynecol. 2016 Jan;127(1):e29-e38. doi: 10.1097/AOG.0000000000001265. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Need for resuscitation at birth	Any intervention in the first 30 minutes, excluding blow-by oxygen	Within 30 minutes of delivery
Other	Neonatal Hypothermia	Defined as rectal temperature below 36 degrees Celsius	Delivery to 72 hours of life
Other	Necrotizing Entercolitis	When systemic, radiographic, and abdominal signs lead to a modified Bell stage 2 or 3	Delivery to 72 hours of life
Other	Intraventricular Hemorrhage Grade 3 or 4 (Severe IVH)	Defined when the extent of brain injury includes a hemorrhage that occupies more than 50% of the lateral ventricle volume	Delivery to 72 hours of life
Other	Feeding Difficulty	inability to take all feeds by mouth, requiring gavage feeds or intravenous supplementation at least once.	Delivery to 72 hours of life
Primary	Neonatal Glucose Concentration	Glucose reported in mg/dL; Hypoglycemia defined as concentration < 40 mg/dL	Delivery to 72 hours of life
Secondary	Length of Hospital Stay	Days in hospital from date of delivery until date of discharge	Delivery to discharge from hospital
Secondary	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
Secondary	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
Secondary	Use of ECMO	Drop in oxygen saturation requiring use of ECMO (extracorporeal membrane oxygenation)	Delivery to 72 hours of life
Secondary	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
Secondary	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
Secondary	Neonatal death	Death of fetus after delivery	Delivery to 30 days of life
Secondary	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
Secondary	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
Secondary	Need for surfactant administration	Need for administration of exogenous surfactant in the setting of neonatal respiratory distress	Delivery to 72 hours of life
Secondary	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