Budesonide With Intratracheal Surfactants in Extremely Preterm Infants

NCT04019106 | Unknown Phase 1 DMC

• 1 other identifier: BITS-03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Bronchopulmonary Dysplasia; Respiratory Distress Syndrome in Premature Infant

Keywords

Surfactant; Budesonide; Steroid; Intratracheal; Preterm; Bronchopulmonary Dysplasia; Respiratory Distress Syndrome; Bovine Lipid Extract Surfactant

Outcome Measures

Primary Outcomes (1)

• 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

  At 24 hour time point following dosing

Secondary Outcomes (18)

• Bronchopulmonary Dysplasia free survival

  at 36 weeks PMA or discharge, whichever comes first

• Neonatal Mortality

  up to 40 weeks PMA or discharge, whichever comes first

• Concentration of Inflammatory Biomarkers in Tracheal Aspirates

  Baseline, 24 hours, 48 hours,1 week, 4 weeks and 36 weeks Gestational Age

• Concentration of Inflammatory Biomarkers in Serum

  Baseline, 24 hours, 48 hours and 1 week.

• Duration of Hospital Stay

  from day 0 (birth date) to 40 weeks

Study Arms (3)

Dosing Level 1

EXPERIMENTAL

0.0625 mg/kg Budesonide in bovine lipid extract surfactant (BLES)

Drug: Budesonide in bovine lipid extract surfactant (BLES)

Dosing Level 2

EXPERIMENTAL

0.125 mg/kg Budesonide in bovine lipid extract surfactant (BLES)

Drug: Budesonide in bovine lipid extract surfactant (BLES)

Dosing Level 3

EXPERIMENTAL

0.25 mg/kg Budesonide in bovine lipid extract surfactant (BLES)

Drug: Budesonide in bovine lipid extract surfactant (BLES)

Interventions

Budesonide in bovine lipid extract surfactant (BLES) DRUG

Budesonide in bovine lipid extract surfactant

Also known as: Pulmicort respule, BLES

Dosing Level 1; Dosing Level 2; Dosing Level 3

Eligibility Criteria

• Age: 1 Hour - 5 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead
• Health Sciences Centre, Winnipeg, Manitoba: collaborator
• St. Boniface Hospital: collaborator
• Manitoba Institute of Child Health: collaborator
• University of Utah: collaborator
• Winnipeg Rh Institute Foundation Inc.: collaborator
• BLES Biochemicals Inc.: collaborator

Study Sites (2)

Children's Hospital-Health Science Centre

Winnipeg, Manitoba, R3E 3P4, Canada

Location

St. Boniface General Hospital

Winnipeg, Manitoba, R3E 3P4, Canada

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Premature Birth; Respiratory Distress Syndrome

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Geert W 't Jong, MD, Ph.D

  Children's Hospital Research Institute of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Geert W 't Jong, MD, Ph.D

CONTACT

(204)789-3206; gtjong@chrim.ca

Abin Chandrakumar, Pharm.D, M.Sc.

CONTACT

(204)594-5359; achandrakumar@chrim.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: July 15, 2019
• Study Start: October 15, 2019
• Primary Completion: October 15, 2020
• Study Completion: January 15, 2021
• Last Updated: July 17, 2019

Record last verified: 2018-08

Locations

CA (2)