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

• Status: Completed
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cynthia McEvoy
• Collaborators: Florida Hospital for Children; Thrasher Research Fund; University of California, San Francisco; University of Florida
• Treatments: Budesonide; Calfactant; Pulmonary Surfactants

Criteria

Inclusion Criteria:

1. > 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)

2. Day of life 3-14 from the date and time of delivery, with the date of birth being DOL 0

3. Intubated and mechanically ventilated and do not anticipate extubation in next 24 hours

Exclusion Criteria:

1. Serious congenital malformations or chromosomal abnormality

2. Likely to be extubated in next 24 hours

3. Clinically unstable

4. Infants who have received systemic steroids prior to dosing with study medication.

5. Infants who have received Indocin, Ibuprofen, or acetaminophen ≤ 96 hours prior to enrollment window ending