se of high frequency oscillatory ventilation for the prevention of chronic lung disease of prematurity: a multicentre trial
Completed
- Conditions
- RespiratoryChronic lung disease
- Registration Number
- ISRCTN98436149
- Lead Sponsor
- Medical Research Council (MRC) (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 800
Inclusion Criteria
1. Gestational age less than 29 weeks
2. Require endotracheal ventilation
3. It is considered appropriate that intensive care is continued
4. No identified major congenital malformation
Exclusion Criteria
Not provided at time of registration
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite variable:<br>1. Death before discharge from neonatal services<br>2. Chronic lung disease, defined as oxygen dependency 36 weeks post menstrual age (PMA)
- Secondary Outcome Measures
Name Time Method 1. Age at death<br>2. Age at final extubation<br>3. Failure of treatment<br>4. Abnormal cerebral ultrasound<br>5. Postnatal use of systematic steroids<br>6. Hearing loss greater than 60 dB<br>7. Pneumothorax<br>8. Age finally out of oxygen<br>9. Pulmonary haemorrhage<br>10. Patent ductus arteriosus<br>11. Retinopathy of prematurity<br>12. Age at discharge from hospital<br><br>Long-term outcome measures:<br>1. Respiratory morbidity over the first two years<br>2. Presence of disability at two years