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Corticosteroid
Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial (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 weeks3 visits
Treatment ~ Varies
Follow Up ~ delivery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~delivery
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 moreAwards & 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
3,943 Previous Clinical Trials
47,792,400 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
2,067 Previous Clinical Trials
2,744,633 Total Patients Enrolled
Andrew Bremer, MDStudy DirectorNICHD Project Scientist
Monica Longo, MDStudy DirectorNICHD Project Scientist
8 Previous Clinical Trials
45,248 Total Patients Enrolled
Rebecca Clifton, PhDPrincipal InvestigatorGeorge Washington University
6 Previous Clinical Trials
19,935 Total Patients Enrolled
Cynthia Gyamfi Bannerman, MDStudy ChairColumbia University