Intratracheal Budesonide/Surfactant Prevents BPD

Summary

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.

Conditions

• Respiratory Distress Syndrome
• Bronchopulmonary Dysplasia

Interventions

DRUG

budesonide

Intra-tracheal instillation of a combination of budesonide/surfactant in preterm infants with RDS to prevent BPD

DRUG

Saline

Intra-tracheal instillation of a combination of saline/surfactant in preterm infants with RDS to prevent BPD

Sponsors & Collaborators

• Taipei Medical University Hospital

  collaborator OTHER

• National Taiwan University Hospital

  collaborator OTHER

• Taipei Veterans General Hospital, Taiwan

  collaborator OTHER_GOV

• Mackay Memorial Hospital

  collaborator OTHER

• Chang Gung Memorial Hospital

  collaborator OTHER

• China Medical University Hospital

  collaborator OTHER

• Seventh Medical Center of PLA General Hospital

  collaborator OTHER

• Guangzhou Women and Children's Medical Center

  collaborator OTHER

• Taichung Veterans General Hospital

  collaborator OTHER

• Taipei Medical University

  lead OTHER

Principal Investigators

• Tsu F Yeh, M.D., Ph.D. · Maternal Child Health Research Center, Taipei Medical University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

30 Minutes

Max Age

4 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-07-01

Primary Completion

2022-06-30

Completion

2022-06-30

Countries

• Taiwan

Study Locations