Status:
RECRUITING
Flow and Grow - The Ideal Time to Wean CPAP Off In Extremely Low Birth Weight Infants
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
Rady Children's Hospital, San Diego
Conditions:
Neonatal Respiratory Failure
Eligibility:
All Genders
Up to 30 years
Phase:
NA
Brief Summary
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) ...
Detailed Description
This is a multicenter, non-blinded, randomized control trial involving premature neonates born between 23 0/7 and 29 6/7 weeks gestational age. The trial will take place in four Neonatal Intensive Car...
Eligibility Criteria
Inclusion
- All infants admitted to the NICU at Jacobs, Rancho Springs, Scripps La Jolla, and Rady Children's Hospital born at \< 30 weeks CGA
- Informed parental consent obtained
Exclusion
- 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)
Key Trial Info
Start Date :
November 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT06123143
Start Date
November 27 2023
End Date
November 1 2028
Last Update
January 8 2025
Active Locations (4)
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1
Scripps La Jolla Rady NICU
La Jolla, California, United States, 92037
2
University of California, San Diego Jacobs Medical Center
La Jolla, California, United States, 92037
3
Rancho Springs Medical Center Rady NICU
Murrieta, California, United States, 92562
4
Rady Children's Hospital-San Diego
San Diego, California, United States, 92123