Evaluation of lung lavage in meconium aspiration syndrome
Phase 3
Completed
- Conditions
- Meconium aspiration syndromeReproductive Health and Childbirth - Complications of newbornRespiratory - Other respiratory disorders / diseases
- Registration Number
- ACTRN12606000290594
- Lead Sponsor
- A/Prof Peter Dargaville
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 66
Inclusion Criteria
Neonates (males and females)with confirmed diagnosis of meconium aspiration syndrome with all of the following:1. birth weight >2.0kgs, gestation >36 weeks.2. <24 hours of age3. ventilated with mean airway pressure >/= 12 cm H2O4. Alveolar-arterial oxygen difference >/= 450 mmHg
Exclusion Criteria
Known or suspected cardiac abnormality. Severe hypoxic ischaemic encephalopathy or congenital anomaly (ie, withdrawal of treatment being considered). Intractable cardiorespiratory instability.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total duration of respiratory support (ventilation plus nasal continuous positive airway pressure) during initial hospitalisation[First hospitalisation]
- Secondary Outcome Measures
Name Time Method Mortality[First hospitalisation];Incidence of pneumothorax[First hospitalisation];Duration of oxygen therapy[First hospitalisation];Intubation and hospitalisation[First hospitalisation];Respiratory morbidity[In 1st year pf life.];Neurodevelopmental outcome[At 2 years.]