NCT03275415

Intratracheal Budesonide/Surfactant Prevents BPD

Completed Phase 4 Last updated 30 May 2023

What this trial tests

Phase 4 trial testing budesonide in Respiratory Distress Syndrome in 310 participants. Completed in 30 June 2022.

Timeline

1 July 2019

Primary endpoint
30 June 2022

30 June 2022

Quick facts

Lead sponsor	Taipei Medical University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	310
Start date	1 July 2019
Primary completion	30 June 2022
Estimated completion	30 June 2022
Sites	1 location across Taiwan

Drugs / interventions tested

• budesonide (BUDESONIDE) — full drug profile →
• Saline

Conditions studied

• Respiratory Distress Syndrome — all drugs for Respiratory Distress Syndrome →
• Bronchopulmonary Dysplasia — all drugs for Bronchopulmonary Dysplasia →

Sponsor

Taipei Medical University

Who can join

Adults 30 Minutes to 4 Hours, any sex, with Respiratory Distress Syndrome or Bronchopulmonary Dysplasia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A double-blind study includes: 1) birth Wt 500-1499 gm, 2) respiratory distress shortly after birth and requires resuscitation 3) failure to NCPAP within 4 hrs after birth, defined as: a) FIO2 ≥ 0.30, pressure \> 5cmH2O b) severe retraction c) apnea d) PCO2 ≥ 60 mmHg. Exclusion criteria: 1) lethal cardiopulmonary status 2) severe congenital anomalies.

Given the COVID19 pandemics, the recruitment became difficult. Under the consideration of scientific and practical consideration, we therefore determine to have a sample of 300, (150 in each group), fulfill the criteria of type I error 0.05, type II error 0.10, power 90% and with an expectation of 30 % improvement of primary outcome (from 60 % in control group to 40 % in the intervention group as original presumed).Appropriate amount of placebo will be used as it does not affect the biophysical property of curosurf (PAS abstract 2017 San Francisco). Primary outcome of study is death or BPD defined by NICHD criteria. Follow up study of neuromotor and cognitive function and pulmonary states will be done at 1-2 years of corrected age.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.