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Corticosteroid
Betamethasone for Neonatal Hypoglycemia
Phase 4
Waitlist Available
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must not have
Prior course of betamethasone during pregnancy
Maternal contraindication to betamethasone
Timeline
Screening 3 weeks
Treatment Varies
Follow Up delivery to 72 hours of life
Awards & highlights
Summary
This trial is investigating whether giving a steroid called betamethasone to late preterm infants before they are born impacts the development of neonatal hypoglycemia.
Who is the study for?
This trial is for single-baby pregnancies where the baby is due a bit early (between 34 and almost 37 weeks). Moms should be planning to deliver in this late preterm period. It's not for twins, pregnancies with major baby health issues, moms who can't take betamethasone, those about to give birth within 12 hours of joining the study, or moms with diabetes before pregnancy.
What is being tested?
The study looks at when to give betamethasone (a steroid) to pregnant women whose babies are coming a little early. The goal is to see if giving it at different times affects the chances of their newborns having low blood sugar right after birth.
What are the potential side effects?
While specific side effects aren't listed here, steroids like betamethasone could cause changes in blood sugar levels and may have other effects on both mom and baby that will be monitored during the trial.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I received betamethasone during my pregnancy.
Select...
I cannot take betamethasone due to health reasons.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ delivery to 72 hours of life
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~delivery to 72 hours of life
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Neonatal Glucose Concentration
Secondary study objectives
Length of Hospital Stay
Need for supplemental oxygen
Need for surfactant administration
+8 moreOther study objectives
Feeding Difficulty
Intraventricular Hemorrhage Grade 3 or 4 (Severe IVH)
Necrotizing Entercolitis
+2 moreTrial Design
2Treatment groups
Active Control
Group I: Late Preterm Steroids 2 DaysActive Control1 Intervention
Group II: Late Preterm Steroids 7 DaysActive Control1 Intervention
Find a Location
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
936 Previous Clinical Trials
1,613,271 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are pregnant with only one baby.I received betamethasone during my pregnancy.I cannot take betamethasone due to health reasons.You are expecting to give birth a little earlier than expected.The baby has died before birth.Severe birth defectsYou are between 34 weeks and 36 weeks and 5 days pregnant.You have diabetes before becoming pregnant.You are pregnant with twins.
Research Study Groups:
This trial has the following groups:- Group 1: Late Preterm Steroids 2 Days
- Group 2: Late Preterm Steroids 7 Days
Awards:
This trial has 5 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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