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
This trial accepts healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Brain NIRS
Other intervention24 hours of Brain regional oxygen saturation by NIRS
Polysomnogram
Other intervention4-5 hours of polysomnogram recording
Reactive oxydative species
Other interventionBlood and urine samples to detect plasma not albumin bound proteins- neuroprostane and isoflurane
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: PIMUNActive comparator 3 interventions
Group B: 48 hours without PIMUNSham comparator 3 interventions
Trial outcomes
Primary outcomes
1
Total Time of Oxygen Saturation <90%
Total cumulative duration (in minutes) that peripheral oxygen saturation (SpO₂) remains below 90%, measured using cardiorespiratory monitoring and oxygen saturation histogram
Time frame
48-hour data baseline versus 48- hour data with PIMUNSecondary outcomes
1
Total Time of Oxygen Saturation <85% and <80%
Cumulative time (in minutes) , derived from continuous cardiorespiratory monitoring and polysomnography (PSG)
Time frame
48-hour data baseline versus 48- hour data with PIMUN2
Neonatal infant pain scale (NIPS)
The Neonatal Infant Pain Scale (NIPS) is a validated behavioral assessment tool used to evaluate pain or discomfort in neonates. It is based on six observable indicators of distress: Parameter Scoring Criteria Facial Expression 0 = Relaxed muscles 1 = Grimace Cry 0 = No cry 1 = Whimper 2 = Vigorous cry Breathing Patterns 0 = Relaxed 1 = Change in breathing (irregular, labored) Arms 0 = Relaxed/neutral 1 = Flexed/extended Legs 0 = Relaxed/neutral1 = Flexed/extended State of Arousal 0 = Sleeping/quiet 1 = Fussy/awake Total Score Range: 0-7 0-2: No pain or mild discomfort 3-4: Moderate pain ≥5: Severe pain Scores are typically assessed by trained nursing staff during clinical or research interventions. The NIPS provides an objective measure of neonatal comfort and can be used to monitor procedural pain, device tolerance, or overall well-being during treatment.
Time frame
48-hour data baseline versus 48- hour data with PIMUN3
Total Time of Heart Rate <100 bpm
Total Time of Heart Rate \<100 bpm/Cumulative time (in minutes) , measured via continuous ECG monitoring and PSG event extraction
Time frame
48-hour data baseline versus 48- hour data with PIMUN4
Number of Apnea Events (Central, Mixed, or Obstructive)
Description: Total count of central, mixed, and obstructive apneas per hour of recording, detected by cardiorespiratory monitoring and PSG. Unit of Measure: Events per hour
Time frame
48-hour data baseline versus 48- hour data with PIMUNOther outcomes
1
Number and type of Safety Events
Report of any adverse event, defined as any skin reaction- apneas requiring resuscitation- increasing therapy of AOP- connection to MV- thermoregulation disturbances- Device failure- etc.
Time frame
During each 48-hour intervention periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
Pontificia Universidad Catolica de Chile
Lead sponsor
Agencia Nacional de Investigación y Desarrollo
Collaborator
Source ClinicalTrials.gov