CompletedPhase 3Phase 4ACTRN12606000290594

Evaluation of lung lavage in meconium aspiration syndrome

A randomised controlled trial of therapeutic lung lavage to reduce the duration of respiratory support required by ventilated newborn infants with meconium aspiration syndrome (MAS)


Sponsor

A/Prof Peter Dargaville

Enrollment

66 participants

Start Date

Mar 1, 2003

Study Type

Interventional

Conditions

Summary

Meconium aspiration syndrome (MAS) is a complex disease of the newborn lung that can cause life-threatening respiratory distress very soon after birth. Current management consists mainly of providing supportive care, rather than removing meconium from the lung to hault or slow disease progression. This multicentre randomised controlled trial will test whether therapeutic lung lavage, using a dilute surfactant preparation, improves outcomes in infants with severe MAS. The study will include a total of 66 newborn infants, who are receiving mechanical ventilation because of MAS. The main outcome measure will be duration of respiratory support; secondary outcomes will be duration of oxygen therpay; duration of hospitalisation, and evidence of chronic lung disease.


Eligibility

Sex: Both males and femalesMin Age: 0 DayssMax Age: 1 Days

Inclusion Criteria1

  • 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 Criteria1

  • Known or suspected cardiac abnormality. Severe hypoxic ischaemic encephalopathy or congenital anomaly (ie, withdrawal of treatment being considered). Intractable cardiorespiratory instability.

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Interventions

Lung lavage with 30 ml/kg surfactant solution (5mgs/ml), administered in 2 aliquots, each lasting 1 minute (under 10 minutes for entire procedure), within 24 hours after birth.

Lung lavage with 30 ml/kg surfactant solution (5mgs/ml), administered in 2 aliquots, each lasting 1 minute (under 10 minutes for entire procedure), within 24 hours after birth.


Locations(1)

New Zealand

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