Prevention of Chronic Lung Disease (CLD) in Preterm Infants

Summary

Pulmonary inflammation plays an important role in the early development of CLD. Postnatal glucocorticoids have been shown effective in the prevention or treatment of CLD with various success. However, systemic glucocorticoid therapy often associated with various short term and long term complications. Therefore, modification of the therapeutic regimen is needed. Inhaled steroid, including inhaled budesonide,have been tried but the results are essentially unsuccessful, most likely due to small airways that the inhaled steroid reaching to the peripheral lungs are limited and unpredictable. Direct instillation of budesonide into the airway has also shown to be ineffective, possibly due to poor distribution of steroid in the lungs.

The investigators hypothesize that intratracheal instillation of budesonide, a strong tropical steroid, using surfactant as vehicle would facilitate the delivery of budesonide to the lung periphery and would inhibit lung inflammation and improve the pulmonary outcome. The result of our pilot study (Pediatrics, 2008) indicated this high possibility.

Conditions

• Respiratory Distress Syndrome
• Chronic Lung Disease of Prematurity

Interventions

DRUG

budesonide

budesonide, 0.25 mg/Kg/dose every 8 hours until the infant requires FIO2 \< 30% or is extubated

DRUG

surfactant and air (placebo)

receive surfactant and air as control through endotracheal route

Sponsors & Collaborators

• National Taiwan University Hospital

  collaborator OTHER

• Taipei Medical University Hospital

  collaborator OTHER

• Cathay General Hospital

  collaborator OTHER

• Chang Gung Memorial Hospital

  collaborator OTHER

• China Medical University, China

  lead OTHER

Principal Investigators

• Tsu F Yeh, M.D. · China Medical University, China

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

30 Minutes

Max Age

4 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-04-30

Primary Completion

2012-12-31

Completion

2013-04-30

Countries

• China