MedTrace Logo

Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial

NCT01222247 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2831

Last updated 2023-03-28

Study results available
· View outcomes & findings →

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

Conditions

  • Pregnancy
  • Respiratory Distress Syndrome
  • Pregnancy Outcomes
  • Preterm Birth

Interventions

DRUG

Betamethasone

The active study drug, betamethasone. 3 mg per ml betamethasone sodium phosphate 3 mg per milliliter betamethasone acetate The first dose of study drug medication will be administered at randomization as 2 ml injection; the next dose of 2 ml will be administered 24 hours later.

DRUG

Placebo

Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • The George Washington University Biostatistics Center

    lead OTHER

Principal Investigators

  • Monica Longo, MD · NICHD Project Scientist

  • Rebecca Clifton, PhD · George Washington University

  • Cynthia Gyamfi Bannerman, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2015-03-31
Completion
2022-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01222247 on ClinicalTrials.gov