RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2023-11-27
Study Completion:2028-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06123143

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 30 Weeks
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. All infants admitted to the NICU at Jacobs, Rancho Springs, Scripps La Jolla, and Rady Children's Hospital born at \< 30 weeks CGA
  2. 2. Informed parental consent obtained
  1. 1. Declined or unable to give informed consent
  2. 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. 3. Intubated for over 4 weeks of life (28 days)

Contacts and Locations

Study Contact

Sandra Leibel, MD
CONTACT
858-249-1702
saleibel@health.ucsd.edu
Sarah Lazar, MPH
CONTACT
858-249-1711
slazar@health.ucsd.edu

Principal Investigator

Sandra Leibel, MD
PRINCIPAL_INVESTIGATOR
University of California, San Diego

Study Locations (Sites)

Scripps La Jolla Rady NICU
La Jolla, California, 92037
United States
University of California, San Diego Jacobs Medical Center
La Jolla, California, 92037
United States
Rancho Springs Medical Center Rady NICU
Murrieta, California, 92562
United States
Rady Children's Hospital-San Diego
San Diego, California, 92123
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

  • Sandra Leibel, MD, PRINCIPAL_INVESTIGATOR, University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-27
Study Completion Date2028-11

Study Record Updates

Study Start Date2023-11-27
Study Completion Date2028-11

Terms related to this study

Keywords Provided by Researchers

  • Neonatal
  • CPAP

Additional Relevant MeSH Terms

  • Neonatal Respiratory Failure