Skip to main content

Summary

at San Francisco, California and other locations
study started
estimated completion:

Description

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.

Official Title

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

Details

This is a phase I/II open-label study to determine the lowest safe, effective dose of budesonide given with calfactant as the vehicle; the investigators will perform an unblinded dose escalation study. The investigators will administer four dosing levels of budesonide suspended in calfactant beginning with 0.025 mg/kg of budesonide administered to 8 extremely low gestational age newborns (ELGANs) who are intubated at 3-10 days of age. Daily doses (at the same dosage) will be administered to infants who remain intubated for a potential of 5 total doses in each patient. Subsequent groups of 8 infants each will receive 0.05 mg/kg, 0.10 mg/kg, and 0.15 mg/kg of budesonide in calfactant (up to 5 total doses in each patient). A total of up to 32 infants will be enrolled in the trial. The investigators will evaluate the clinical, laboratory and safety data from each group of treated infants to 28 days of age before moving to the next dosing level of budesonide.

Keywords

Bronchopulmonary Dysplasia (BPD) Bronchopulmonary dysplasia Pulmonary Surfactant Steroids Extremely low gestational age Budesonide Calfactant Pulmonary Surfactants

Eligibility

You can join if…

  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

You CAN'T join if...

  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

Locations

  • University of California, San Francisco not yet accepting patients
    San Francisco, California, 94143, United States
  • Oregon Health ans Science University accepting new patients
    Portland, Oregon, 97239, United States
  • Vanderbilt Children's Hospital accepting new patients
    Nashville, Tennessee, 37232, United States
  • University of Florida, Jacksonville accepting new patients
    Jacksonville, Florida, 32209, United States
  • Florida Hospital for Children accepting new patients
    Orlando, Florida, 32803, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Cynthia McEvoy
ID
NCT02907593
Phase
Phase 1/2
Study Type
Interventional
Last Updated
October 17, 2017
I’m interested in this study!