Actively Recruiting
Efficacy of PIMUN by Reducing Intermittent Hypoxia Events
Led by Pontificia Universidad Catolica de Chile · Updated on 2026-02-09
20
Participants Needed
2
Research Sites
91 weeks
Total Duration
On this page
Sponsors
P
Pontificia Universidad Catolica de Chile
Lead Sponsor
A
Agencia Nacional de Investigación y Desarrollo
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of PIMUN by Reducing Intermittent Hypoxia Events
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Clinica San Carlos de Apoquindo
Santiago, Santiago Metropolitan, Chile
Active, Not Recruiting
2
UC Christus Clinical Hospital
Santiago, Santiago Metropolitan, Chile
Actively Recruiting
Research Team
P
Paulina A Toso, MD
CONTACT
A
Alvaro J González, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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