This is a phase I/II open-label study to determine the lowest, safe, effective dose of
budesonide given with calfactant as the vehicle.
Drug: Budesonide in Calfactant
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT02907593
Ages eligible for Study
up to 14 Days
Genders eligible for Study
Accepts Healthy Volunteers
> 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
Serious congenital malformations or chromosomal abnormality
Likely to be extubated in next 24 hours
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
All locations for NCT02907593
United States (5)
University of California, San Francisco
San Francisco, California, United States, 94143
University of Florida
Jacksonville, Florida, United States, 32209
Orlando, Florida, United States, 32803
Oregon Health and Science
Portland, Oregon, United States, 97239
Vanderbilt Children's Hospital
Nashville, Tennessee, United States, 37232
View full eligibility
Tris trial is registered with FDA with number: NCT02907593. The sponsor of the trial is Cynthia McEvoy and it is looking for 25 volunteers for the current phase.
Official trial title: Steroids and Surfactant in Extremely Low Gestation Age Infants Pilot Dose Escalation Trial
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