NCT04019106

Budesonide With Intratracheal Surfactants in Extremely Preterm Infants

Pharmacokinetics and Pharmacodynamics of Budesonide With Intratracheal Surfactant (BITS) Administration in Preterm Infants < 29 Weeks Gestational Age

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Manitoba · Academic / Other
• Sex: All
• Age: 1 Hour – 5 Days
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Bronchopulmonary Dysplasia
• Respiratory Distress Syndrome in Premature Infant

Interventions

Type	Name	Description
DRUG	Budesonide in bovine lipid extract surfactant (BLES)	Budesonide in bovine lipid extract surfactant

Timeline

• Start date: 2019-10-15
• Primary completion: 2020-10-15
• Completion: 2021-01-15
• First posted: 2019-07-15
• Last updated: 2019-07-17

Locations

2 sites across 1 country: Canada