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Efficacy of PIMUN by Reducing Intermittent Hypoxia Events

RecruitingNAAges any - 30 DaysAllPontificia Universidad Catolica de Chile
NCT07396103 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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) Exclusion Criteria: * 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
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What it tests

  • Brain NIRS
  • Polysomnogram
  • Reactive oxydative species
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Where

2 sites
Clinica San Carlos de Apoquindo
Santiago, Chile
UC Christus Clinical Hospital
Santiago, Chile
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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