Efficacy of PIMUN by Reducing Intermittent Hypoxia Events
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 30
SponsorPontificia Universidad Catolica de Chile
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Brain NIRS
- Polysomnogram
- Reactive oxydative species
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Pontificia Universidad Catolica de Chile
Lead sponsor
Agencia Nacional de Investigación y Desarrollo
Collaborator
Source ClinicalTrials.gov