Actively Recruiting
Flow and Grow - The Ideal Time to Wean CPAP Off In Extremely Low Birth Weight Infants
Led by University of California, San Diego · Updated on 2026-01-20
130
Participants Needed
5
Research Sites
257 weeks
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
R
Rady Children's Hospital, San Diego
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Flow and Grow - The Ideal Time to Wean CPAP Off In Extremely Low Birth Weight Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants born before 30 weeks gestational age admitted to one of the participating neonatal intensive care units
- Informed parental consent obtained
You will not qualify if you...
- Declined or unable to give informed consent
- Infants with known congenital anomalies or complications needing long-term support (such as pulmonary hypoplasia, airway defects, genetic syndromes, necrotizing enterocolitis, spontaneous intestinal perforation, or surgical conditions)
- Infants intubated for more than 28 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Palomar Medical Center Rady NICU
Escondido, California, United States, 92029
Actively Recruiting
2
Scripps La Jolla Rady NICU
La Jolla, California, United States, 92037
Actively Recruiting
3
University of California, San Diego Jacobs Medical Center
La Jolla, California, United States, 92037
Actively Recruiting
4
Rancho Springs Medical Center Rady NICU
Murrieta, California, United States, 92562
Actively Recruiting
5
Rady Children's Hospital-San Diego
San Diego, California, United States, 92123
Actively Recruiting
Research Team
S
Sandra Leibel, MD
CONTACT
S
Sarah Lazar, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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