Aerosolized surfactant in the first hour of life
An open label, randomised, controlled pilot study to evaluate the safety and efficacy of aerosolised surfactant in the first hour of life in preterm infants with respiratory distress syndrome (RDS)
School of Women’s and Infants’ Health (SWIH)
110 participants
Oct 15, 2010
Interventional
Conditions
Summary
Surfactant replacement is the mainstay in prevention and therapy of respiratory distress syndrome (RDS) in preterm neonates. Early treatment with surfactant reduces mortality, and incidence of chronic lung disease (CLD) and air leaks in preterm infants at risk of RDS. Current therapy consists of instilling a liquid bolus of surfactant into the trachea through an endotracheal tube, followed by mechanical ventilation of variable duration. This treatment actually requires the patient to be admitted to a level III care nursery and a risk of ventilator induced lung injury. We propose a new approach to surfactant treatment for moderately preterm infants born with respiratory distress, as well as for more mature infants born in a non-tertiary hospital setting. By using nebulised surfactant, we propose that babies will have their mild-moderate respiratory disease treated without the need for invasive ventilation or transport to a tertiary neonatal unit.
Eligibility
Inclusion Criteria3
- Preterm infants with a gestational age (GA) between 29 w 0 d and 33 w 6 d AND
- late preterm and term infants with a GA between 34 w 0 d and 39 w 6 d
- with clinical or radiological signs of RDS requiring FiO2 of 0.22- 0.30 to maintain a peripheral haemoxyglobin saturation of 88-94%.
Exclusion Criteria1
- cardiorespiratory instability, cardiothoracic malformations, obvious chromosomal aberrations
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Interventions
Nebulisation of animal derived lung surfactant commenced within the first hour of life, whilst infant supported on Constant Positive Airway Pressure (CPAP). Surfactant will be redosed by nebulisation 12 h after initial dosing if infant remains on CPAP and continues to have evidence of respiratory distress and/or oxygen requirement. Curosurf dose will be 200 mg/kg for 29 w 0 d - 33 w 6 d gestation infants, and 100 mg/kg for newborns born at 34 w 0 d - 39 w 6 d gestation.
Locations(1)
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ACTRN12610000857000