Bronchopulmonary Dysplasia Clinical Trial
Official title:
Pharmacokinetics and Pharmacodynamics of Budesonide With Intratracheal Surfactant (BITS) Administration in Preterm Infants < 29 Weeks Gestational Age
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.
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.
A total of 30 subjects will be recruited from 2 neonatal intensive care units:
1. Children's Hospital-Health Sciences Centre (HSC), Winnipeg
2. St. Boniface General Hospital, Winnipeg, MB
3 groups of 10 infants each will receive single dose of intratracheal budesonide (0.0625
mg/kg, 0.125 mg/kg, and 0.25 mg/kg) with BLES surfactant (5 ml/kg). PK/PD analysis will be
done using clinical parameters, serum biomarkers, tracheal aspirate biomarkers and plasma
budesonide levels obtained at fixed intervals.
The duration of subject participation will involve 12-17 weeks for the clinical intervention,
depending on gestational age at birth and discharge date. Participants will be followed until
40 weeks or discharge, whichever comes first.
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