Study of Lung Recruitment Maneuver Effects on Ventilation in Preterm Infants Receiving Minimally Invasive Surfactant Therapy

What this Trial Is About

Preterm infants born before 36 weeks gestation often have immature lungs and difficulty breathing independently. To support them, respiratory machines like ventilators and treatments such as surfactant replacement therapy are used. This trial evaluates whether briefly increasing air pressure from a CPAP machine before giving minimally invasive surfactant therapy MIST improves lung ventilation and aeration compared to the current standard without this maneuver. The study focuses on infants born between 24 and 32 weeks gestation receiving CPAP and MIST. Participants are randomly assigned to one of two groups the control group receives MIST with no change to baseline CPAP positive end expiratory pressure PEEP, typically set at 7-8 cmH2O the intervention group undergoes a lung recruitment manoeuvre LRM involving a transient increase of PEEP to 10 cmH2O for 20 minutes before MIST, with PEEP returning to baseline afterward. MIST involves delivering surfactant through a thin catheter while the infant is on non-invasive respiratory support. The trial is blinded and controlled to assess the impact of LRM on lung function. During the trial, infants ventilation patterns are monitored using electrical impedance tomography before and after MIST to measure changes in lung aeration. Researchers will also track clinical outcomes such as surfactant dosing, need for intubation, oxygen levels, days on respiratory support, and incidence of air leaks up to 12 months. The study requires infants to be less than 72 hours old and clinically stable, with treatment delivered within 90 minutes of randomization. Participation lasts through the neonatal intensive care admission and follow-up periods as specified.

deMISTify: The Impact of Ventilator Pressure Levels During Minimally Invasive Surfactant Therapy on Lung Aeration in Preterm Infants