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Evaluation of lung lavage in meconium aspiration syndrome

Phase 3
Completed
Conditions
Meconium aspiration syndrome
Reproductive Health and Childbirth - Complications of newborn
Respiratory - 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
NameTimeMethod
Total duration of respiratory support (ventilation plus nasal continuous positive airway pressure) during initial hospitalisation[First hospitalisation]
Secondary Outcome Measures
NameTimeMethod
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.]
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