Neonatal Respiratory Failure
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURELung ultrasound-guided respiratory management
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.
Sponsors
Tufts Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Clinical care teams cannot be blinded due to the nature of the intervention. Outcome assessors and statisticians analyzing study outcomes will remain blinded to group assignment. Therefore it will be single masked.
Intervention model description
Participants are randomized in a 1:1 ratio to either the lung ultrasound-guided respiratory management group or the standard care group. Both groups are followed concurrently to compare outcomes.
Eligibility
Sex/Gender
ALL
Age
0 Years to 1 Years
Healthy volunteers
Yes
Inclusion criteria
* Infants admitted to the Tufts Medical Center NICU * Requiring invasive or non-invasive respiratory support * Requiring surfactant therapy * Parental or guardian informed consent obtained
Exclusion criteria
* Major congenital anomalies * Known chromosomal abnormalities * Congenital diaphragmatic hernia * Decision for comfort care * Surfactant administered prior to transfer from outside hospital (only excluded for surfactant decisions)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of NICU stay (days) | From date of NICU admission to date of hospital discharge up to one year |
Secondary
| Measure | Time frame |
|---|---|
| Duration of any respiratory support | From date of initiation of respiratory support to date of discontinuation of respiratory support, up to one year |
| Duration of non-invasive respiratory support | 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 | 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 | From date of weaning respiratory support, to date of re-escalation of respiratory support if needed, up to 72 hours |
| Need for reintubation | From date of extubation, to date of reintubation, up to 72 hours. |
| Number of surfactant doses administered | Number of surfactant doses quantified over the course through study completion, up to an average of 1 year. |
| Mortality prior to discharge | From date of birth until the date of death from any cause, assessed up to one year. |
Outcome results
None listed