Determining the best time to stop CPAP for premature infants
Flow and Grow - A CPAP Management Strategy for Preterm Infants to Support Lung Growth. A Randomized, Prospective, Multi-center Study
NA · University of California, San Diego · NCT06123143
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | N/A to 30 Weeks |
| Sex | All |
| Sponsor | University of California, San Diego (other) |
| Locations | 5 sites (Escondido, California and 4 other locations) |
| Trial ID | NCT06123143 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are infants born at less than 30 weeks gestational age who are admitted to participating NICUs.
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.
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 performed: Previous studies have indicated that delaying CPAP weaning can significantly reduce failure rates, suggesting that this approach may be beneficial.
Eligibility criteria
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 this trial is running
Escondido, California and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neonatal Respiratory Failure, Neonatal, CPAP