Determining the best time to stop CPAP for premature infants
Official title: Flow and Grow - A CPAP Management Strategy for Preterm Infants to Support Lung Growth. A Randomized, Prospective, Multi-center Study
Run by University of California, San Diego · NCT06123143 · Data updated 2026-11-12
This study is testing the best time to stop using CPAP for premature babies born very early to see if it helps them breathe better and stay healthy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 30 Weeks |
| Sex | All |
| Enrollment | 130 (estimated) |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 5 sites (Escondido, California and 4 other locations) |
| Status | Recruiting |
| Started | November 27, 2023 |
| Main results expected | November 2028 |
| Study ends | November 2028 |
| Registry record updated | January 20, 2026 |
| Trial ID | NCT06123143 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are infants born at less than 30 weeks gestational age who are admitted to participating NICUs.
✕Probably not a fit
Patients with congenital anomalies or complications requiring long-term support, or those intubated for over 28 days, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the optimal timing for weaning Continuous Positive Airway Pressure (CPAP) in extremely low birth weight infants born before 30 weeks of gestation. It is a multicenter, non-blinded, randomized control trial conducted across four Neonatal Intensive Care Units (NICUs) within the Rady Children's/University of California, San Diego network. The study aims to recruit 130 infants and will compare the duration of respiratory support and oxygen exposure between those following a structured weaning protocol and those weaned earlier. The goal is to reduce CPAP weaning failure rates and improve outcomes for these vulnerable infants.
Why it matters
Potential benefit: If successful, this study could lead to improved respiratory outcomes and reduced rates of chronic lung disease in premature infants.
How similar studies have gone: Previous studies have indicated that delaying CPAP weaning can significantly reduce failure rates, suggesting that this approach may be beneficial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. All infants admitted to the NICU at Jacobs, Rancho Springs, Scripps La Jolla, Rady Children's Hospital, or Palomar born at \< 30 weeks CGA 2. Informed parental consent obtained Exclusion Criteria: 1. Declined or unable to give informed consent 2. 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) 3. Intubated for over 4 weeks of life (28 days)
Where it's running
-
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
Study contacts
- Principal investigator: Sandra Leibel, MD — University of California, San Diego
- Study coordinator: Sandra Leibel, MD
- Email: saleibel@health.ucsd.edu
- Phone: 858-249-1702
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Cervical screening and care options for women living with HIV who test positive for high-risk HPV
This study tests different ways to screen and manage high-risk HPV in women with HIV to see what might work best for them.
-
NPT Feasibility in Knee Osteoarthritis
This study tests whether NRPT can be safely given to adults with knee osteoarthritis and whether it shows early signals of benefit.
-
Recovery-oriented suicide prevention for young people at clinical high risk for psychosis
This program tests a peer-supported, clinician-led suicide prevention group for young people at clinical high risk for psychosis to see if it helps reduce suicidal thoughts and support recovery.
-
Anti-inflammatory diet for people with lupus
This study tests whether an anti-inflammatory diet can affect symptoms and biological markers in people with systemic lupus erythematosus who are already taking Cellcept or Mycophenolate.
-
Biomarkers for opioid use and pain response after trauma and surgery
This study tests whether microRNA patterns can predict long-term opioid risk in adults after trauma or surgery.
-
Precision pain management plan using suzetrigine in high-risk surgical patients
In people at high risk for long-term opioid use after surgery, this trial tests whether taking suzetrigine around the time of surgery reduces overall opioid use in the first 14 days postoperatively.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.