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Steroids and Surfactant in Extremely Low Gestation Age Infants Dose Escalation Trial

NCT02907593 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-04-04

Study results available
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Summary

This is a phase I/II open-label study to determine the lowest, safe, effective dose of budesonide given with calfactant as the vehicle.

Conditions

  • Bronchopulmonary Dysplasia (BPD)

Interventions

DRUG

Budesonide in Calfactant

Budesonide in Calfactant

Sponsors & Collaborators

  • Thrasher Research Fund

    collaborator OTHER

  • University of Florida

    collaborator OTHER

  • Florida Hospital for Children

    collaborator OTHER

  • University of California, San Francisco

    collaborator OTHER

  • Cynthia McEvoy

    lead OTHER

Principal Investigators

  • Cynthia McEvoy, MD, MCR · Oregon Health and Science University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
3 Days
Max Age
14 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-04-30
Completion
2018-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT02907593 on ClinicalTrials.gov