Condition or disease | Intervention/treatment | Phase |
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Bronchopulmonary Dysplasia Respiratory Distress Syndrome in Premature Infant | Drug: Budesonide in bovine lipid extract surfactant (BLES) | Phase 1 Phase 2 |
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:
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Pharmacokinetics and Pharmacodynamics of Budesonide With Intratracheal Surfactant (BITS) Administration in Preterm Infants < 29 Weeks Gestational Age |
Estimated Study Start Date : | October 15, 2019 |
Estimated Primary Completion Date : | October 15, 2020 |
Estimated Study Completion Date : | January 15, 2021 |
Arm | Intervention/treatment |
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Experimental: Dosing Level 1
0.0625 mg/kg Budesonide in bovine lipid extract surfactant (BLES)
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Drug: Budesonide in bovine lipid extract surfactant (BLES)
Budesonide in bovine lipid extract surfactant
Other Names:
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Experimental: Dosing Level 2
0.125 mg/kg Budesonide in bovine lipid extract surfactant (BLES)
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Drug: Budesonide in bovine lipid extract surfactant (BLES)
Budesonide in bovine lipid extract surfactant
Other Names:
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Experimental: Dosing Level 3
0.25 mg/kg Budesonide in bovine lipid extract surfactant (BLES)
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Drug: Budesonide in bovine lipid extract surfactant (BLES)
Budesonide in bovine lipid extract surfactant
Other Names:
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Ages Eligible for Study: | up to 5 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Geert W 't Jong, MD, Ph.D | (204)789-3206 | gtjong@chrim.ca | |
Contact: Abin Chandrakumar, Pharm.D, M.Sc. | (204)594-5359 | achandrakumar@chrim.ca |
Canada, Manitoba | |
Children's Hospital-Health Science Centre | |
Winnipeg, Manitoba, Canada, R3E 3P4 | |
Contact: Geert 't Jong, MD, PhD 2047893206 gtjong@chrim.ca | |
Contact: Abin Chandrakumar, PharmD, MSc 2045945359 achandrakumar@chrim.ca | |
Sub-Investigator: Mary Seshia, MB,BCh,FRCP | |
St. Boniface General Hospital | |
Winnipeg, Manitoba, Canada, R3E 3P4 | |
Sub-Investigator: Ruben Alvaro, MD, FAAP |
Principal Investigator: | Geert W 't Jong, MD, Ph.D | Children's Hospital Research Institute of Manitoba |
Tracking Information | |||||||
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First Submitted Date ICMJE | August 15, 2018 | ||||||
First Posted Date ICMJE | July 15, 2019 | ||||||
Last Update Posted Date | July 17, 2019 | ||||||
Estimated Study Start Date ICMJE | October 15, 2019 | ||||||
Estimated Primary Completion Date | October 15, 2020 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Area under the curve from serial budesonide levels [ Time Frame: At 24 hour time point following dosing ] Blood samples will be drawn from patients to determine the serum budesonide levels to determine the area under the curve
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Budesonide With Intratracheal Surfactants in Extremely Preterm Infants | ||||||
Official Title ICMJE | Pharmacokinetics and Pharmacodynamics of Budesonide With Intratracheal Surfactant (BITS) Administration in Preterm Infants < 29 Weeks Gestational Age | ||||||
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. A total of 30 subjects will be recruited from 2 neonatal intensive care units:
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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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE | Drug: Budesonide in bovine lipid extract surfactant (BLES)
Budesonide in bovine lipid extract surfactant
Other Names:
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Unknown status | ||||||
Estimated Enrollment ICMJE |
30 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | January 15, 2021 | ||||||
Estimated Primary Completion Date | October 15, 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | up to 5 Days (Child) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Canada | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04019106 | ||||||
Other Study ID Numbers ICMJE | BITS-03 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | University of Manitoba | ||||||
Study Sponsor ICMJE | University of Manitoba | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University of Manitoba | ||||||
Verification Date | August 2018 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |