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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 7 months
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Scripps La Jolla Rady NICU
RECRUITING
La Jolla
University of California, San Diego Jacobs Medical Center
RECRUITING
La Jolla
Rancho Springs Medical Center Rady NICU
RECRUITING
Murrieta
Rady Children's Hospital-San Diego
RECRUITING
San Diego
Contact Information
Primary
Sandra Leibel, MD
saleibel@health.ucsd.edu
858-249-1702
Backup
Sarah Lazar, MPH
slazar@health.ucsd.edu
858-249-1711
Time Frame
Start Date: 2023-11-27
Estimated Completion Date: 2028-11
Participants
Target number of participants: 130
Treatments
Experimental: Standardized NIS Wean
A standardized maintenance/weaning protocol will be implemented for the treatment group (standardized NIS wean). All infants in the treatment group will remain on NIS until either 32 or 34 weeks CGA, depending on their gestational age at birth. Infants born at 27 6/7 weeks or less will continue on NIS until at least 34 weeks if they are in the treatment group, whereas infants born between 28 0/7 and 29 6/7 weeks will stay on NIS until at least 32 weeks if they are in the treatment group. The weaning protocol in the treatment group will incorporate algorithms outlining stability criteria, failure criteria, and algorithms for registered nurses (RNs) and respiratory therapists (RTs), including steps to take in such situations. The control group will be weaned according to the unit's or medical team's practices.
No_intervention: Control
Babies in the control group (non-standardized wean) will be weaned based on unit specific practices.
Related Therapeutic Areas
Sponsors
Collaborators: Rady Children's Hospital, San Diego
Leads: University of California, San Diego

This content was sourced from clinicaltrials.gov