Flow and Grow - The Ideal Time to Wean CPAP Off In Extremely Low Birth Weight Infants
Recruiting now · Not applicable
Conditions studied: Neonatal Respiratory Failure
In brief
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.
Key facts
- Study ID
- NCT06123143
- Run by
- University of California, San Diego
- People needed
- 130
- Starts
- 2023-11-27
- Expected to finish
- 2028-11-01
- Last updated by the study team
- 2026-01-20
Who can join
Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All infants admitted to the NICU at Jacobs, Rancho Springs, Scripps La Jolla, Rady Children's Hospital, or Palomar born at < 30 weeks CGA
- Informed parental consent obtained
You may not qualify if…
- Declined or unable to give informed consent
- Infants with known congenital anomalies or complications that require long term support (pulmonary hypoplasia, airway defects, genetic syndromes, necrotizing enterocolitis (NEC), spontaneous intestinal perforation (SIP), anything surgical)
- Intubated for over 4 weeks of life (28 days)
Where it is running
- Palomar Medical Center Rady NICU — Escondido, California, United States (enrolling)
- Scripps La Jolla Rady NICU — La Jolla, California, United States (enrolling)
- University of California, San Diego Jacobs Medical Center — La Jolla, California, United States (enrolling)
- Rancho Springs Medical Center Rady NICU — Murrieta, California, United States (enrolling)
- Rady Children's Hospital-San Diego — San Diego, California, United States (enrolling)
Full record on ClinicalTrials.gov
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