NCT05791331

REspiratory MEchanics for Delivering Individualised Exogenous Surfactant

A Randomized Controlled Trial of Oscillatory Mechanics Versus Oxygenation-based Criteria for Surfactant Therapy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 458 (estimated)
• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Academic / Other
• Sex: All
• Age: 27 Weeks – 33 Weeks
• Healthy volunteers: Not accepted

Summary

This study is an interventional, non-pharmacological, multicentric, randomized, controlled, superiority, non-profit study. Its primary objective is to evaluate if the administration of surfactant based on FOT assessment will allow a 5-day reduction in the duration of respiratory support as compared to standard practice in preterm infants between 27+0 and 32+6 weeks' gestation. The secondary objectives are: 1. to determine if a lung mechanics-based approach for administering surfactant will change treatment timing; and 2. to assess the impact of the novel approach on other neonatal general outcomes. The study will take place within the neonatal intensive care units. Non-invasive respiratory support will be delivered by nasal CPAP with a starting pressure of 5-8 cmH2O. FiO2 will be titrated in order to achieve the target SpO2 91-95%. Infants matching the clinical criteria for inclusion will be randomized in two arms following the current data protection and confidentiality regulations. Central, computer-generated randomization (allocation 1:1) with variable block sizes according to gestational age will be used. Infants will be stratified according to gestational age (27+0 -28+6 weeks; 29+0 -30+6 weeks; 31+0 -32+6 weeks) and center. Study Arms: A) Surfactant administration following oxygenation-based criteria (clinical assessment) (control) B) Surfactant administration following both lung mechanics assessment OR oxygenation-based criteria (clinical assessment) (intervention).

Conditions

• Respiratory Distress Syndrome in Premature Infant

Interventions

Type	Name	Description
OTHER	Surfactant administration following lung mechanics assessment in addition to clinical assessment	Surfactant is administered following oxygenation-based criteria and if the Xrs is ≤ -23.3 cmH2O\*s /L
OTHER	Surfactant administration following clinical assessment	Surfactant is administered following oxygenation-based criteria

Timeline

• Start date: 2023-05-18
• Primary completion: 2025-05-30
• Completion: 2025-12-31
• First posted: 2023-03-30
• Last updated: 2023-03-30