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NCT06123143 · ClinicalTrials.gov registry record · NA
Flow and Grow - The Ideal Time to Wean CPAP Off In Extremely Low Birth Weight Infants
A NA study of Neonatal Respiratory Failure, sponsored by University of California, San Diego.
- Recruiting
- Registry status
- NA
- Development phase
- 130
- Enrollment target
- 5
- Study locations
NCT06123143: Recruiting NA study of Neonatal Respiratory Failure, sponsored by University of California, San Diego.
NCT06123143 is a NA study of Neonatal Respiratory Failure that is actively recruiting participants, run by University of California, San Diego. The registered enrollment target is 130 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). The trial reports 5 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06123143, a NA study of Neonatal Respiratory Failure, is actively recruiting participants, sponsored by University of California, San Diego.
- RECRUITING
- Registry status
- NA
- Development phase
- 130 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
Number of participants needing more support and/or with increased sleep stimulation events after weaning off of CPAP/NIS.
Conditions Studied
Interventions
- OTHER Standardized/structured CPAP weaning protocol
Study Locations (5)
California
- Palomar Medical Center Rady NICU - Escondido
- Scripps La Jolla Rady NICU - La Jolla
- University of California, San Diego Jacobs Medical Center - La Jolla
- Rancho Springs Medical Center Rady NICU - Murrieta
- Rady Children's Hospital-San Diego - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2023-11-27 |
| Est. Completion | 2028-11 |
| Phase | NA |
What NCT06123143 shows while recruiting
NCT06123143 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Neonatal Respiratory Failure appearing as the primary indexed condition, and to 1 intervention - of which Standardized/structured CPAP weaning protocol is the first listed.
NCT06123143 lists 5 locations in 1 state (California).
Frequently Asked Questions
What is clinical trial NCT06123143 about?
NCT06123143 is a clinical study titled "Flow and Grow - The Ideal Time to Wean CPAP Off In Extremely Low Birth Weight Infants". 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 weanin...
What is the current status of trial NCT06123143?
This trial is currently recruiting. It is a NA study. The enrollment target is 130 participants. The study started on 2023-11-27. Estimated completion is 2028-11.
What conditions does trial NCT06123143 study?
This clinical trial studies the following conditions: Neonatal Respiratory Failure.
What interventions are being tested in trial NCT06123143?
The interventions under investigation include: Standardized/structured CPAP weaning protocol (OTHER).
Who is sponsoring clinical trial NCT06123143?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06123143 being conducted?
This trial has 5 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06123143's enrollment target sits among peer trials
130 733rd of 2000 higher than 1,258 of 2,000 other NA trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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