Status:
UNKNOWN
Budesonide With Intratracheal Surfactants in Extremely Preterm Infants
Lead Sponsor:
University of Manitoba
Collaborating Sponsors:
Health Sciences Centre, Winnipeg, Manitoba
St. Boniface Hospital
Conditions:
Bronchopulmonary Dysplasia
Respiratory Distress Syndrome in Premature Infant
Eligibility:
All Genders
1-5 years
Phase:
PHASE1
PHASE2
Brief 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.
Detailed Description
Premature infants of gestational age less than 29 weeks with respiratory distress syndrome and clinical indication for surfactant administration will be recruited for this Phase I/II open-label study....
Eligibility Criteria
Inclusion
- Male or female infant born between 23 and 28+6 weeks of GA
- Infant diagnosed with RDS according to clinical protocol criteria
- Able to adhere to surfactant administration protocol
- The patient is born in the study centre.
- 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.
- 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
- Older than five days at inclusion.
- Presence of known clinically significant congenital heart disease or other major congenital malformation
- 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.
Key Trial Info
Start Date :
October 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 15 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04019106
Start Date
October 15 2019
End Date
January 15 2021
Last Update
July 17 2019
Active Locations (2)
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1
Children's Hospital-Health Science Centre
Winnipeg, Manitoba, Canada, R3E 3P4
2
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R3E 3P4