Efficacy of PIMUN by Reducing Intermittent Hypoxia Events
Recruiting now · Not applicable
Conditions studied: Preterm, Apnea of Prematurity, Hypoxemia
In brief
The goal of this clinical trial is to learn if the use of PIMUN(medical device) works to reduce the intermittent hypoxemia of 24-34 weeks of birth gestational age babies. . It will also learn about the safety of the use of PIMUN. The main questions it aims to answer are: Does PIMUN lower the time of oxygen saturation under 90%? What medical problems do participants have using PIMUN? Researchers will compare the use of PIMUN during 48 hours to 48 hours of usual treatments (not using PIMUN). Participants will: Use/ or not use of PIMUN for a 48 hours period- randomly assigned. Regional brain oxygenation by near infrared spectroscopy (NIRS) monitoring at the first day of each 48 hours period. 4-6 hours of polysomnography at the second day of each intervention. Plasma and urine stress oxygen metabolites at the end of each 48-hours intervention.
Key facts
- Study ID
- NCT07396103
- Run by
- Pontificia Universidad Catolica de Chile
- People needed
- 20
- Starts
- 2024-09-01
- Expected to finish
- 2026-05-31
- Last updated by the study team
- 2026-02-09
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Preterm infants with a gestational age at birth <34 weeks
- Age <30 days at the time of enrollment
- Documented diagnosis of apnea of prematurity (AOP)
You may not qualify if…
- Currently receiving mechanical ventilation (MV)
- Presence of major congenital malformations
- Clinically unstable or critically ill at the time of screening
- Active sepsis or undergoing treatment for sepsis
- Intraventricular hemorrhage (IVH) Grade > II
- Receiving sedatives or anticonvulsant medications
Where it is running
- UC Christus Clinical Hospital — Santiago, Santiago Metropolitan, Chile (enrolling)
- Clinica San Carlos de Apoquindo — Santiago, Santiago Metropolitan, Chile
Full record on ClinicalTrials.gov
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