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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000290594

Acronym

lessMAS

Enrollment

Registered

2004-10-25

Start date

2003-03-01

Completion date

2008-09-26

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to 1 Days

Healthy volunteers

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.

Outcome results