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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04869709
Other study ID # APP-21-01310
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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