Condition: Neonatal Respiratory Failure · Sponsor: University of California, San Diego
Preterm neonates born at less than 30 weeks' gestation are commonly maintained on invasive or non-invasive respiratory support to facilitate gas exchange. While non-invasive respiratory support (NIS) can be gradually reduced over time as the infant grows, most weaning strategies often lead to weaning failure. This failure is evidenced by an increase in significant events such as apneas, desaturations, and/or bradycardias, increased work of breathing, or an inability to oxygenate or ventilate, resulting in escalated respiratory support. Although the optimal approach to weaning NIS remains uncertain, neonatal units that delay Continuous Positive Airway Pressure (CPAP) weaning until 32-34 weeks corrected gestational age exhibit lower rates of chronic lung disease. Therefore, the investigators aim to compare the duration on respiratory support and oxygen exposure in infants born at less than 30 weeks' gestational age who undergo a structured weaning protocol that includes remaining on CPAP until at least 32-34 weeks corrected gestational age (CGA). The hypothesis posits that preterm infants following a structured weaning protocol, including maintaining CPAP until a specific gestational age, will demonstrate lower rates of weaning failure off CPAP (defined as requiring more support and/or experiencing increased stimulation events 72 hours after CPAP weaning) than those managed according to the medical team's discretion.
This description comes directly from the study's public registry record.
Sandra Leibel, MD · 858-249-1702 · saleibel@health.ucsd.edu
Sarah Lazar, MPH · 858-249-1711 · slazar@health.ucsd.edu
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| Palomar Medical Center Rady NICU | Escondido, California, United States | Recruiting |
| Scripps La Jolla Rady NICU | La Jolla, California, United States | Recruiting |
| University of California, San Diego Jacobs Medical Center | La Jolla, California, United States | Recruiting |
| Rancho Springs Medical Center Rady NICU | Murrieta, California, United States | Recruiting |
| Rady Children's Hospital-San Diego | San Diego, California, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06123143