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)

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000857000

Acronym

CureNeb

Enrollment

Registered

2010-10-14

Start date

2010-10-15

Completion date

2012-05-12

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

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.

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.

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 Hours

Healthy volunteers

Inclusion criteria

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 criteria

cardiorespiratory instability, cardiothoracic malformations, obvious chromosomal aberrations

Outcome results