Late Preterm Corticosteroids and Neonatal Hypoglycemia

April 29, 2021 updated by: Elizabeth Sasso, University of Southern California

Timing of Late Preterm Corticosteroid Administration and Neonatal Hypoglycemia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
210

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • LAC+USC Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Elizabeth Sasso, MD
        • Sub-Investigator:
          • Genevieve Mazza, MD
        • Sub-Investigator:
          • Kristen Uquillas, MD
        • Sub-Investigator:
          • Michelle Nguyen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Late Preterm Steroids 2 Days
Drug: Betamethasone Sodium Phosphate
Betamethasone Sodium Phosphate 12mg IM q24h for 2 doses
Other Names:
  • Celestone
Active Comparator: Late Preterm Steroids 7 Days
Drug: Betamethasone Sodium Phosphate
Betamethasone Sodium Phosphate 12mg IM q24h for 2 doses
Other Names:
  • Celestone

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Neonatal Glucose Concentration
Time Frame: Delivery to 72 hours of life
Glucose reported in mg/dL; Hypoglycemia defined as concentration < 40 mg/dL
Delivery to 72 hours of life

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Length of Hospital Stay
Time Frame: Delivery to discharge from hospital
Days in hospital from date of delivery until date of discharge
Delivery to discharge from hospital
Use of CPAP or High Flow Nasal Cannula
Time Frame: 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
Delivery to 72 hours of life
Need for supplemental oxygen
Time Frame: 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
Delivery to 72 hours of life
Use of ECMO
Time Frame: Delivery to 72 hours of life
Drop in oxygen saturation requiring use of ECMO (extracorporeal membrane oxygenation)
Delivery to 72 hours of life
Use of mechanical ventilation
Time Frame: Delivery to 72 hours of life
Drop in oxygen saturation and/or inability to maintain an airway requiring use of mechanical ventilation
Delivery to 72 hours of life
Stillbirth
Time Frame: 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
From administration of the intervention (betamethasone) to delivery
Neonatal death
Time Frame: Delivery to 30 days of life
Death of fetus after delivery
Delivery to 30 days of life
Respiratory distress syndrome (RDS)
Time Frame: 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
Delivery to 72 hours of life
Transient Tachypnea of the Newborn
Time Frame: 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
Delivery to 72 hours of life
Need for surfactant administration
Time Frame: Delivery to 72 hours of life
Need for administration of exogenous surfactant in the setting of neonatal respiratory distress
Delivery to 72 hours of life
Neonatal pneumonia
Time Frame: 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.
Delivery to 72 hours of life

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Need for resuscitation at birth
Time Frame: Within 30 minutes of delivery
Any intervention in the first 30 minutes, excluding blow-by oxygen
Within 30 minutes of delivery
Neonatal Hypothermia
Time Frame: Delivery to 72 hours of life
Defined as rectal temperature below 36 degrees Celsius
Delivery to 72 hours of life
Necrotizing Entercolitis
Time Frame: Delivery to 72 hours of life
When systemic, radiographic, and abdominal signs lead to a modified Bell stage 2 or 3
Delivery to 72 hours of life
Intraventricular Hemorrhage Grade 3 or 4 (Severe IVH)
Time Frame: 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
Delivery to 72 hours of life
Feeding Difficulty
Time Frame: Delivery to 72 hours of life
inability to take all feeds by mouth, requiring gavage feeds or intravenous supplementation at least once.
Delivery to 72 hours of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APP-21-01310

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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