This single-center randomized controlled study will compare lung ultrasound-guided respiratory management with standard clinical care in infants requiring respiratory support. The primary outcome measure is length of NICU stay.
Infants, especially premature infants, frequently require respiratory support in the neonatal intensive care unit (NICU). Lung ultrasound is a bedside, radiation-free tool that can assess lung aeration and guide respiratory management, but its effect on clinical outcomes has not been evaluated in a U.S. randomized trial. This single-center randomized controlled study will compare lung ultrasound-guided respiratory management with standard clinical care in premature infants requiring respiratory support. In the intervention group, lung ultrasound scores will guide surfactant administration, weaning non-invasive respiratory support, and weaning from non-invasive respiratory support to room air using predefined thresholds. The control group will use standard care to guide surfactant administration, weaning non-invasive respiratory support, and weaning from non-invasive respiratory support to room air. The primary outcome is length of NICU stay. Secondary outcomes include duration of respiratory support, time on non-invasive respiratory support, time to successful weaning to room air, need for re-intubation, surfactant dosing, and mortality prior to discharge. This study aims to determine whether lung ultrasound-guided management can improve respiratory care and reducive hospital length of stay in infants requiring respiratory suppport.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
64
Scheduled lung ultrasounds are performed to guide decisions about surfactant administration, non-invasive respiratory support weaning, and transition to room air using predefined lung ultrasound score thresholds.
Length of NICU stay (days)
Time frame: From date of NICU admission to date of hospital discharge up to one year
Duration of any respiratory support
Time frame: From date of initiation of respiratory support to date of discontinuation of respiratory support, up to one year
Duration of non-invasive respiratory support
Time frame: From date of initiation of non-invasive respiratory support to date of discontinuation of non-invasive respiratory support up to one year.
Time to successful weaning to room air
Time frame: From date of initiation of respiratory support to date of sustained room air without support for at least 48h, up to one year.
Weaning failure
Time frame: From date of weaning respiratory support, to date of re-escalation of respiratory support if needed, up to 72 hours
Need for reintubation
Time frame: From date of extubation, to date of reintubation, up to 72 hours.
Number of surfactant doses administered
Time frame: Number of surfactant doses quantified over the course through study completion, up to an average of 1 year.
Mortality prior to discharge
Time frame: From date of birth until the date of death from any cause, assessed up to one year.
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