← Back to Search

Corticosteroid

Betamethasone for Acute Respiratory Distress Syndrome (ALPS Trial)

Phase 3
Waitlist Available
Led By Rebecca Clifton, PhD
Research Sponsored by The George Washington University Biostatistics Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up delivery through hospital discharge
Awards & highlights
Pivotal Trial

Summary

This is a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in the late preterm infant. The use of antenatal corticosteroids has been shown to be beneficial in women at risk for preterm delivery prior to 34 weeks but has not been evaluated in those likely to deliver in the late preterm period

Eligible Conditions
  • Acute Respiratory Distress Syndrome
  • Pregnancy
  • Premature Birth
  • Respiratory Distress Syndrome
  • Pregnancy Outcomes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~delivery
This trial's timeline: 3 weeks for screening, Varies for treatment, and delivery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Neonatal Composite Outcome
Secondary study objectives
Birth Weight
Birth Weight Less Than 10th Percentile
Gestational Age at Delivery
+25 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: BetamethasoneActive Control1 Intervention
A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart
Group II: PlaceboPlacebo Group1 Intervention
A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,923 Previous Clinical Trials
47,757,979 Total Patients Enrolled
The George Washington University Biostatistics CenterLead Sponsor
26 Previous Clinical Trials
108,501 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,050 Previous Clinical Trials
2,728,355 Total Patients Enrolled
~188 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top