A Phase 1/2 interventional study of Budesonide in bovine lipid extract surfactant (BLES) in Bronchopulmonary Dysplasia and Respiratory Distress Syndrome in Premature Infant, sponsored by University of Manitoba. Status unknown at 2 sites in Canada. Open to participants aged 1 Hour to 5 Days. Per ClinicalTrials.gov, last updated 2019-07-17.
Sponsored by University of Manitoba · Phase 1/2, Interventional, and Prevention
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:
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.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →University of Manitoba is the lead sponsor of 542 studies on the registry; 87 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
0.0625 mg/kg Budesonide in bovine lipid extract surfactant (BLES)
Drug: Budesonide in bovine lipid extract surfactant (BLES)
0.125 mg/kg Budesonide in bovine lipid extract surfactant (BLES)
Drug: Budesonide in bovine lipid extract surfactant (BLES)
0.25 mg/kg Budesonide in bovine lipid extract surfactant (BLES)
Drug: Budesonide in bovine lipid extract surfactant (BLES)
Budesonide in bovine lipid extract surfactant
Also known as: Pulmicort respule, BLES
Area under the curve from serial budesonide levels
Blood samples will be drawn from patients to determine the serum budesonide levels to determine the area under the curve
Time frame: At 24 hour time point following dosing
Bronchopulmonary Dysplasia free survival
NICHD criteria will be used to diagnose and grade the infants for presence of BPD.
Time frame: at 36 weeks PMA or discharge, whichever comes first
Neonatal Mortality
Survival of the infants
Time frame: up to 40 weeks PMA or discharge, whichever comes first
Concentration of Inflammatory Biomarkers in Tracheal Aspirates
Tracheal aspirates will be centrifuged to isolate a large aggregate surfactant fraction that will be assayed for both phospholipid (surfactant recovery) and total protein concentration. The supernatant fraction after surfactant isolation will be assayed for total protein, and selected cytokines (IL-1 β, IL-6, IL-8, IL-10, CCL2 and TNF-ɑ)
Time frame: Baseline, 24 hours, 48 hours,1 week, 4 weeks and 36 weeks Gestational Age
Concentration of Inflammatory Biomarkers in Serum
Cytokines IL-1 β, IL-6, IL-8, IL-10, CCL2 and TNF-ɑ will be analyzed in serum samples obtained from the infants following BITS administration using commercially available ELISA kits.
Time frame: Baseline, 24 hours, 48 hours and 1 week.
Duration of Hospital Stay
Time frame: from day 0 (birth date) to 40 weeks
VentilationStrategy
Duration and modality of ventilation used in the preterm infants
Time frame: till 36 weeks PMA or discharge, whichever comes first
Respiratory Severity Score
The product of Fraction of inspired oxygen and mean airway pressure will be used to estimate the respiratory severity score
Time frame: at baseline and till 36 weeks PMA or discharge, whichever comes first
Duration of Supplemental Oxygen
Time frame: till 36 weeks PMA or discharge, whichever comes first
Level of Supplemental Oxygen Administered
the concentration of supplemental oxygen given at discharge or 36 weeks PMA compared to baseline.
Time frame: at baseline and at 36 week Post menstrual age or discharge, whichever comes first
Presence of Respiratory Support
the presence or absence of any method of respiratory support at discharge or 36 weeks PMA compared to baseline.
Time frame: at 36 week Post menstrual age or discharge, whichever comes first
Percentage of Participants with Pulmonary Hemorrhage
Clinical signs of pallor, cyanosis, bradycardia, apnoea and blood gas changes. Radiographic evidences of patchy infiltrates to complete opacification of lung fields.
Time frame: at baseline and 48 hours after budesonide with surfactant administration
Percentage of Participants with Hypothalamic pituitary axis (HPA) suppression
Cortisol levels will be measured
Time frame: at 0 and 24 hours after dosing
Percentage of Participants with Pneumothorax on Chest X-ray
Identified in X-ray as hyperlucent shadow outside the lungs without pulmonary vascular markings, with or without mediastinal shift
Time frame: at baseline and 48 hours after budesonide with surfactant administration
Percentage of Participants with Spontaneous Intestinal Perforation (SIP) on abdominal X-ray
Abdominal X-ray showing presence of free air. Presence or absence of SIP will be compared across the 3 dosing groups and within the dosing groups.
Time frame: at baseline and 48 hours after budesonide with surfactant administration
Percentage of Participants with Intra-ventricular Hemorrhage
presence or absence of will be compared across the 3 dosing groups and within the dosing groups.
Time frame: at baseline and 48 hours after budesonide with surfactant administration
Percentage of Participants with Sepsis
As per the third international consensus definitions for sepsis and septic shock (Sepsis-3)
Time frame: at baseline and till 36 weeks PMA or discharge, whichever comes first
Percentage of Participants with Necrotising Enterocolitis (NEC)
presence or absence of NEC will be compared across the 3 dosing groups and within the dosing groups.
Time frame: 48 hours after budesonide with surfactant administration
Percentage of Participants with Severe Retinopathy at Prematurity
retinopathy of ≥grade III will be recorded
Time frame: baseline and 48 hours after budesonide with surfactant administration
Plan to share: Undecided
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Respiratory Distress Syndrome→
University of Manitoba