Late Preterm Corticosteroids and Neonatal Hypoglycemia
Timing of Late Preterm Corticosteroid Administration and Neonatal Hypoglycemia
1 other identifier
interventional
210
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2021
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2021
CompletedFirst Posted
Study publicly available on registry
May 3, 2021
CompletedStudy Start
First participant enrolled
July 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2024
CompletedMay 3, 2021
April 1, 2021
2 years
April 9, 2021
April 29, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Neonatal Glucose Concentration
Glucose reported in mg/dL; Hypoglycemia defined as concentration \< 40 mg/dL
Delivery to 72 hours of life
Secondary Outcomes (11)
Length of Hospital Stay
Delivery to discharge from hospital
Use of CPAP or High Flow Nasal Cannula
Delivery to 72 hours of life
Need for supplemental oxygen
Delivery to 72 hours of life
Use of ECMO
Delivery to 72 hours of life
Use of mechanical ventilation
Delivery to 72 hours of life
- +6 more secondary outcomes
Other Outcomes (5)
Need for resuscitation at birth
Within 30 minutes of delivery
Neonatal Hypothermia
Delivery to 72 hours of life
Necrotizing Entercolitis
Delivery to 72 hours of life
- +2 more other outcomes
Study Arms (2)
Late Preterm Steroids 2 Days
ACTIVE COMPARATORLate Preterm Steroids 7 Days
ACTIVE COMPARATORInterventions
Betamethasone Sodium Phosphate 12mg IM q24h for 2 doses
Eligibility Criteria
You may qualify if:
- Singleton pregnancy
- Gestational age 34 0/7 weeks to 36 5/7 weeks
- Planned delivery in late preterm period
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
LAC+USC Medical Center
Los Angeles, California, 90033, United States
Related Publications (6)
Practice Bulletin No. 159: Management of Preterm Labor. Obstet Gynecol. 2016 Jan;127(1):e29-e38. doi: 10.1097/AOG.0000000000001265.
PMID: 26695585BACKGROUNDLiggins 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. No abstract available.
PMID: 4561295BACKGROUNDGyamfi-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.
PMID: 26842679BACKGROUNDSociety 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. No abstract available.
PMID: 26992737BACKGROUNDKamath-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.
PMID: 27342043BACKGROUNDUquillas 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.
PMID: 32060360BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Obstetrics & Gynecology
Study Record Dates
First Submitted
April 9, 2021
First Posted
May 3, 2021
Study Start
July 1, 2021
Primary Completion
July 1, 2023
Study Completion
July 1, 2024
Last Updated
May 3, 2021
Record last verified: 2021-04