Actively Recruiting

Phase Not Applicable
Age: 0 - 30Weeks
All Genders
NCT06123143

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

Led by University of California, San Diego · Updated on 2026-01-20

130

Participants Needed

5

Research Sites

257 weeks

Total Duration

On this page

Sponsors

U

University of California, San Diego

Lead Sponsor

R

Rady Children's Hospital, San Diego

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 0 - 30Weeks
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Infants born before 30 weeks gestational age admitted to one of the participating neonatal intensive care units
  • Informed parental consent obtained
Not Eligible

You will not qualify if you...

  • Declined or unable to give informed consent
  • Infants with known congenital anomalies or complications needing long-term support (such as pulmonary hypoplasia, airway defects, genetic syndromes, necrotizing enterocolitis, spontaneous intestinal perforation, or surgical conditions)
  • Infants intubated for more than 28 days

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Palomar Medical Center Rady NICU

Escondido, California, United States, 92029

Actively Recruiting

2

Scripps La Jolla Rady NICU

La Jolla, California, United States, 92037

Actively Recruiting

3

University of California, San Diego Jacobs Medical Center

La Jolla, California, United States, 92037

Actively Recruiting

4

Rancho Springs Medical Center Rady NICU

Murrieta, California, United States, 92562

Actively Recruiting

5

Rady Children's Hospital-San Diego

San Diego, California, United States, 92123

Actively Recruiting

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Research Team

S

Sandra Leibel, MD

CONTACT

S

Sarah Lazar, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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