TerminatedPhase 2Phase 3ACTRN12610000857000

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)


Sponsor

School of Women’s and Infants’ Health (SWIH)

Enrollment

110 participants

Start Date

Oct 15, 2010

Study Type

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

Sex: Both males and femalesMin Age: 0 HourssMax Age: 1 Hours

Plain Language Summary

Simplified for easier understanding

This study tests whether giving a lung-coating medication (surfactant) as a mist in the first hour of life can help premature and newborn babies who have trouble breathing. It is for newborns between 29 and 40 weeks gestational age who show signs of respiratory distress syndrome.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

WA, Australia

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