Budesonide With Intratracheal Surfactants in Extremely Preterm Infants

• Status: Unknown status
• Trial end date: 2021-01-15
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase I/II trial in preterm infants aimed at identifying the optimal dose of budesonide with bovine lipid extract surfactant as vehicle for intratracheal administration.

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

Details

• Lead Sponsor: University of Manitoba
• Collaborators: BLES Biochemicals Inc.; Health Sciences Centre, Winnipeg, Manitoba; Manitoba Institute of Child Health; St. Boniface General Hospital Research Centre; St. Boniface Hospital; University of Utah; Winnipeg Rh Institute Foundation Inc.
• Treatments: Budesonide; Pulmonary Surfactants

Criteria

Inclusion Criteria:

1. Male or female infant born between 23 and 28+6 weeks of GA

2. Infant diagnosed with RDS according to clinical protocol criteria

3. Able to adhere to surfactant administration protocol

4. The patient is born in the study centre.

5. Subject's parent(s)/legal guardian(s) has provided signed and dated informed consent and authorization to use protected health information, as required by national and local regulations.

6. In the investigator's opinion, the subject's parent(s)/legal guardian(s) understand(s) and can comply with protocol requirements, instructions, and protocol-stated restrictions, and is likely to complete the study as planned.

Exclusion Criteria:

1. Older than five days at inclusion.

2. Presence of known clinically significant congenital heart disease or other major congenital malformation

3. Subjects with clinically significant laboratory abnormalities which are deemed by the investigator to represent a safety risk to participation in this study. Other laboratory parameters outside the reference range for the subject's age may be included if the investigator considers the abnormalities unlikely to introduce additional risk factors and will not interfere with data interpretation.