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RECRUITING
NCT06123143
NA

Flow and Grow - The Ideal Time to Wean CPAP Off In Extremely Low Birth Weight Infants

Sponsor: University of California, San Diego

View on ClinicalTrials.gov

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) 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.

Official title: Flow and Grow - A CPAP Management Strategy for Preterm Infants to Support Lung Growth. A Randomized, Prospective, Multi-center Study

Key Details

Gender

All

Age Range

Any - 30 Weeks

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2023-11-27

Completion Date

2028-11

Last Updated

2026-01-20

Healthy Volunteers

No

Interventions

OTHER

Standardized/structured CPAP weaning protocol

Standardized/structured CPAP weaning protocol up to 32 or 34 weeks gestational age (GA) (based on GA at birth) for infants born at less than 30 weeks GA.

Locations (5)

Palomar Medical Center Rady NICU

Escondido, California, United States

Scripps La Jolla Rady NICU

La Jolla, California, United States

University of California, San Diego Jacobs Medical Center

La Jolla, California, United States

Rancho Springs Medical Center Rady NICU

Murrieta, California, United States

Rady Children's Hospital-San Diego

San Diego, California, United States