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

Stopped early · Phase 1/Phase 2

Conditions studied: Bronchopulmonary Dysplasia (BPD)

In brief

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

Key facts

Study ID

NCT02907593

Run by

Cynthia McEvoy

People needed

25

Starts

2016-09-01

Expected to finish

2018-04-01

Last updated by the study team

2025-04-04

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• > 23 0/7 and < 27 6/7 weeks of gestational age based on center's best estimate of due date (using earliest obstetrical ultrasound, last menstrual period, examination, and other pertinent available information)
• Day of life 3-14 from the date and time of delivery, with the date of birth being DOL 0
• Intubated and mechanically ventilated and do not anticipate extubation in next 24 hours

You may not qualify if…

• Serious congenital malformations or chromosomal abnormality
• Likely to be extubated in next 24 hours
• Clinically unstable
• Infants who have received systemic steroids prior to dosing with study medication.
• Infants who have received Indocin, Ibuprofen, or acetaminophen ≤ 96 hours prior to enrollment window ending

Where it is running

• University of California, San Francisco — San Francisco, California, United States
• University of Florida, Jacksonville — Jacksonville, Florida, United States
• Florida Hospital for Children — Orlando, Florida, United States
• Oregon Health ans Science University — Portland, Oregon, United States
• Vanderbilt Children's Hospital — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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