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Budesonide With Intratracheal Surfactants in Extremely Preterm Infants

NCT04019106 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-07-17

No results posted yet for this study

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

Interventions

DRUG

Budesonide in bovine lipid extract surfactant (BLES)

Budesonide in bovine lipid extract surfactant

Sponsors & Collaborators

  • Health Sciences Centre, Winnipeg, Manitoba

    collaborator OTHER

  • St. Boniface Hospital

    collaborator OTHER

  • Manitoba Institute of Child Health

    collaborator INDUSTRY

  • University of Utah

    collaborator OTHER

  • Winnipeg Rh Institute Foundation Inc.

    collaborator UNKNOWN

  • BLES Biochemicals Inc.

    collaborator UNKNOWN

  • University of Manitoba

    lead OTHER

Principal Investigators

  • Geert W 't Jong, MD, Ph.D · Children's Hospital Research Institute of Manitoba

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
1 Hour
Max Age
5 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-15
Primary Completion
2020-10-15
Completion
2021-01-15

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04019106 on ClinicalTrials.gov