Clinical trial NCT04869709: Late Preterm Corticosteroids and Neonatal Hypoglycemia
Official title: Timing of Late Preterm Corticosteroid Administration and Neonatal Hypoglycemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Neonatal Hypoglycemia
Prematurity
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 210
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Neonatal Glucose Concentration
timeFrame: Delivery to 72 hours of life
Secondary outcomes:
measure: Length of Hospital Stay
timeFrame: Delivery to discharge from hospital
measure: Use of CPAP or High Flow Nasal Cannula
timeFrame: Delivery to 72 hours of life
measure: Need for supplemental oxygen
timeFrame: Delivery to 72 hours of life
measure: Use of ECMO
timeFrame: Delivery to 72 hours of life
measure: Use of mechanical ventilation
timeFrame: Delivery to 72 hours of life
measure: Stillbirth
timeFrame: From administration of the intervention (betamethasone) to delivery
measure: Neonatal death
timeFrame: Delivery to 30 days of life
measure: Respiratory distress syndrome (RDS)
timeFrame: Delivery to 72 hours of life
measure: Transient Tachypnea of the Newborn
timeFrame: Delivery to 72 hours of life
measure: Need for surfactant administration
timeFrame: Delivery to 72 hours of life
measure: Neonatal pneumonia
timeFrame: Delivery to 72 hours of life
Other outcomes:
measure: Need for resuscitation at birth
timeFrame: Within 30 minutes of delivery
measure: Neonatal Hypothermia
timeFrame: Delivery to 72 hours of life
measure: Necrotizing Entercolitis
timeFrame: Delivery to 72 hours of life
measure: Intraventricular Hemorrhage Grade 3 or 4 (Severe IVH)
timeFrame: Delivery to 72 hours of life
measure: Feeding Difficulty
timeFrame: Delivery to 72 hours of life
Locations:
city: Los Angeles
country: United States
facility: LAC+USC Medical Center
state: California
Study officials:
References:
citation: Practice Bulletin No. 159: Management of Preterm Labor. Obstet Gynecol. 2016 Jan;127(1):e29-e38. doi: 10.1097/AOG.0000000000001265.
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. No abstract available.
citation: 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.
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. No abstract available.
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.
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.