Brief Title
Steroids and Surfactant in Extremely Low Gestation Age Infants Dose Escalation Trial
Official Title
Steroids and Surfactant in Extremely Low Gestation Age Infants Pilot Dose Escalation Trial
Brief 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.
Detailed Description
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.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
The clinical and anti-inflammatory efficacy of escalating doses of budesonide suspended in calfactant and given into the lungs of ELGANs by monitoring respiratory severity score (RSS).
Secondary Outcome
Adverse Events/Subject Safety
Condition
Bronchopulmonary Dysplasia (BPD)
Intervention
Budesonide in Calfactant
Study Arms / Comparison Groups
0.025 mg/kg Budesonide
Description: 0.025 mg/kg Budesonide in Calfactant
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
25
Start Date
September 2016
Completion Date
April 2018
Primary Completion Date
April 2018
Eligibility 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
Gender
All
Ages
N/A - 14 Days
Accepts Healthy Volunteers
No
Contacts
Cynthia McEvoy, MD, MCR, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02907593
Organization ID
SASSIE-001
Responsible Party
Sponsor-Investigator
Study Sponsor
Cynthia McEvoy
Collaborators
Thrasher Research Fund
Study Sponsor
Cynthia McEvoy, MD, MCR, Principal Investigator, Oregon Health and Science University
Verification Date
October 2018