PretermNCT07396103
Efficacy of PIMUN by Reducing Intermittent Hypoxia Events
A study testing Brain NIRS, Polysomnogram and Reactive oxydative species in people with Preterm and Apnea of Prematurity, run by Pontificia Universidad Catolica de Chile at 2 sites in Chile.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 30 daysHealthy volunteers can take part
- Conditions the study is for
- Preterm, Apnea of Prematurity, Hypoxemia
- What is being tested?
- Brain NIRS, Polysomnogram and Reactive oxydative species
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesChile
- Study dates
- 1 Sep 2024to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 30 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Chile2 sites, 1 recruiting
- Active, not recruiting
Clinica San Carlos de Apoquindo
Santiago, Santiago Metropolitan
- Recruiting
UC Christus Clinical Hospital
Santiago, Santiago Metropolitan
Paulina Toso, MD, +56993459661, ptoso@med.puc.cl
About this study
Official title: Clinical Study of Intermittent Hypoxia Reduction Using PIMUN: Efficacy Proof-of-Concept
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).
Read more
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.
Read the detailed description
Preterm infants frequently experience intermittent hypoxia (IH) events despite current treatments, leading to potential neurodevelopmental and systemic sequelae. Many of these episodes are related to an ineffective respiratory drive, a central component of apnea of prematurity (AOP). Previous research has shown that dorsal and extremity stimulation can elicit spontaneous respiratory effort in preterm infants. Several clinical studies have demonstrated that mechanized stimulation can reduce the number of apneas and the total time of oxygen saturation below 90%, a key indicator of IH severity.
Building on prior work, the investigators developed and optimized a stimulation protocol that reliably triggers effective breathing. This protocol was incorporated into a novel medical device called PIMUN. PIMUN consists of a soft cotton garment with an integrated inflatable dorsal chamber. The system includes hardware that captures and releases ambient air to generate pulsatile dorsal stimulation according to a proprietary software algorithm. The device operates using electro-mechanical energy and has been designed to ensure safety and comfort during neonatal use.
This pilot, randomized, crossover experimental study aims to evaluate whether pulsatile dorsal kinesthetic stimulation delivered by PIMUN can reduce the total duration of intermittent hypoxia (defined as oxygen saturation <90%) in preterm infants. Secondary analyses include evaluation of deeper desaturation thresholds (<85% and <80%), heart rate parameters, frequency and type of apneas, resuscitation needs, supplemental oxygen requirements, oxidative stress markers, sleep architecture, and regional brain oxygen saturation. Risk monitoring will include assessment of thermoregulation, skin integrity, comfort (NIPS scale), and device performance and safety alarms.
Eligible participants will be preterm infants under 34 weeks of gestation, within the first month of life, and not requiring mechanical ventilation. Each subject will undergo two intervention periods (with and without PIMUN) in randomized order, separated by a washout period. Continuous monitoring using cardiorespiratory and sleep recording systems will allow precise measurement of oxygen saturation, apnea characteristics, heart rate, and sleep stages. Blood and urine samples will be analyzed for oxidative stress markers.
The investigators hypothesize that PIMUN stimulation will decrease total time spent under hypoxic thresholds and reduce the duration and frequency of apneic events without compromising safety, thermoregulation, or sleep quality. This study is expected to generate proof-of-concept data supporting the efficacy and safety of pulsatile dorsal stimulation as an adjunctive approach to managing apnea of prematurity.
- Conditions
- Preterm, Apnea of Prematurity, Hypoxemia
- Being tested
- Brain NIRS, Polysomnogram, Reactive oxydative species
- Medical subject headings
- Premature Birth, Apnea, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain NIRSOther
24 hours of Brain regional oxygen saturation by NIRS
PolysomnogramOther
4-5 hours of polysomnogram recording
Reactive oxydative speciesOther
Blood and urine samples to detect plasma not albumin bound proteins- neuroprostane and isoflurane
| Study group | Role | What they receive |
|---|---|---|
| PIMUN | Active comparator | 48 hours of dorsal stimulation by PIMUN. Continous cardiorespiratory monitorization- Brain NIRS first 24 hours- 4-5 hours of Polysomnogram at the second day. Blood and urine samples at the finish. Receives: Other: Brain NIRS; Other: Polysomnogram; Other: Reactive oxydative species |
| 48 hours without PIMUN | Sham comparator | 48 hours without PIMUN. Continous cardiorespiratory monitorization- Brain NIRS first 24 hours- 4-5 hours of Polysomnogram at the second day. Blood and urine samples at the finish. Receives: Other: Brain NIRS; Other: Polysomnogram; Other: Reactive oxydative species |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48-hour data baseline versus 48- hour data with PIMUN
Secondary outcomes (8)
Total Time of Oxygen Saturation <85% and <80%
Cumulative time (in minutes) , derived from continuous cardiorespiratory monitoring and polysomnography (PSG)
Measured: 48-hour data baseline versus 48- hour data with PIMUN
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.
Measured: 48-hour data baseline versus 48- hour data with PIMUN
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
Measured: 48-hour data baseline versus 48- hour data with PIMUN
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
Measured: 48-hour data baseline versus 48- hour data with PIMUN
Duration of Desaturation Episodes
Length of individual desaturation episodes categorized as <10 seconds, 10-20 seconds, or >20 seconds, obtained from event data extraction.
Unit of Measure: Seconds per episode
Measured: 48-hour data baseline versus 48- hour data with PIMUN
REM and Non-REM Sleep Duration
Total time spent in REM and non-REM sleep stages, determined from polysomnography recordings.
Unit of Measure: Minutes
Measured: baseline versus during the use of PIMUN
Need for Resuscitation or Respiratory Support
Frequency of episodes requiring resuscitation, supplemental oxygen, or connection to mechanical ventilation as recorded by nursing staff.
Unit of Measure: Number of events
Measured: 48-hour data baseline versus 48- hour data with PIMUN
Oxidative Stress Marker Levels
Change in oxidative stress biomarkers (e.g., plasma carbonyls, urinary isoprostanes) from baseline to end of intervention period.
Unit of Measure: Concentration (e.g., μmol/L or ng/mL)
Measured: baseline versus after 48- hour using PIMUN
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start1 Sep 2024
- Primary completion30 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PretermStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- experimental, randomized, crossover, not blinded, pilot study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Agencia Nacional de Investigación y Desarrollo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396103
- Sponsor's protocol ID
- 210406008-3
- Status last verified
- Oct 2025
- First submitted
- 6 Nov 2024
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Intermittent Hypoxia Reduction Using PIMUN: Efficacy Proof-of-Concept
- ClinicalTrials.gov ID
- NCT07396103
- Acronym / sponsor ID
- 210406008-3
- Conditions
- Preterm, Apnea of Prematurity, Hypoxemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- Agencia Nacional de Investigación y Desarrollo
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Preterm infants frequently experience intermittent hypoxia (IH) events despite current treatments, leading to potential neurodevelopmental and systemic sequelae. Many of these episodes are related to an ineffective respiratory drive, a central component of apnea of prematurity (AOP). Previous research has shown that dorsal and extremity stimulation can elicit spontaneous respiratory effort in preterm infants. Several clinical studies have demonstrated that mechanized stimulation can reduce the number of apneas and the total time of oxygen saturation below 90%, a key indicator of IH severity.
Building on prior work, the investigators developed and optimized a stimulation protocol that reliably triggers effective breathing. This protocol was incorporated into a novel medical device called PIMUN. PIMUN consists of a soft cotton garment with an integrated inflatable dorsal chamber. The system includes hardware that captures and releases ambient air to generate pulsatile dorsal stimulation according to a proprietary software algorithm. The device operates using electro-mechanical energy and has been designed to ensure safety and comfort during neonatal use.
This pilot, randomized, crossover experimental study aims to evaluate whether pulsatile dorsal kinesthetic stimulation delivered by PIMUN can reduce the total duration of intermittent hypoxia (defined as oxygen saturation <90%) in preterm infants. Secondary analyses include evaluation of deeper desaturation thresholds (<85% and <80%), heart rate parameters, frequency and type of apneas, resuscitation needs, supplemental oxygen requirements, oxidative stress markers, sleep architecture, and regional brain oxygen saturation. Risk monitoring will include assessment of thermoregulation, skin integrity, comfort (NIPS scale), and device performance and safety alarms.
Eligible participants will be preterm infants under 34 weeks of gestation, within the first month of life, and not requiring mechanical ventilation. Each subject will undergo two intervention periods (with and without PIMUN) in randomized order, separated by a washout period. Continuous monitoring using cardiorespiratory and sleep recording systems will allow precise measurement of oxygen saturation, apnea characteristics, heart rate, and sleep stages. Blood and urine samples will be analyzed for oxidative stress markers.
The investigators hypothesize that PIMUN stimulation will decrease total time spent under hypoxic thresholds and reduce the duration and frequency of apneic events without compromising safety, thermoregulation, or sleep quality. This study is expected to generate proof-of-concept data supporting the efficacy and safety of pulsatile dorsal stimulation as an adjunctive approach to managing apnea of prematurity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- experimental, randomized, crossover, not blinded, pilot study
| Arm | Type | Receives |
|---|---|---|
| PIMUN | Active comparator | Other: Brain NIRS, Other: Polysomnogram, Other: Reactive oxydative species48 hours of dorsal stimulation by PIMUN. Continous cardiorespiratory monitorization- Brain NIRS first 24 hours- 4-5 hours of Polysomnogram at the second day. Blood and urine samples at the finish. |
| 48 hours without PIMUN | Sham comparator | Other: Brain NIRS, Other: Polysomnogram, Other: Reactive oxydative species48 hours without PIMUN. Continous cardiorespiratory monitorization- Brain NIRS first 24 hours- 4-5 hours of Polysomnogram at the second day. Blood and urine samples at the finish. |
Who may qualify
- Ages
- Up to 30 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain NIRS24 hours of Brain regional oxygen saturation by NIRS | Other | 48 hours without PIMUN, PIMUN |
| Polysomnogram4-5 hours of polysomnogram recording | Other | 48 hours without PIMUN, PIMUN |
| Reactive oxydative speciesBlood and urine samples to detect plasma not albumin bound proteins- neuroprostane and isoflurane | Other | 48 hours without PIMUN, PIMUN |
Primary outcome
Total Time of Oxygen Saturation <90%
Time frame: 48-hour data baseline versus 48- hour data with PIMUN
Total cumulative duration (in minutes) that peripheral oxygen saturation (SpO₂) remains below 90%, measured using cardiorespiratory monitoring and oxygen saturation histogram
8 secondary outcomes
Total Time of Oxygen Saturation <85% and <80%
Time frame: 48-hour data baseline versus 48- hour data with PIMUN
Neonatal infant pain scale (NIPS)
Time frame: 48-hour data baseline versus 48- hour data with PIMUN
Total Time of Heart Rate <100 bpm
Time frame: 48-hour data baseline versus 48- hour data with PIMUN
Number of Apnea Events (Central, Mixed, or Obstructive)
Time frame: 48-hour data baseline versus 48- hour data with PIMUN
Duration of Desaturation Episodes
Time frame: 48-hour data baseline versus 48- hour data with PIMUN
REM and Non-REM Sleep Duration
Time frame: baseline versus during the use of PIMUN
Need for Resuscitation or Respiratory Support
Time frame: 48-hour data baseline versus 48- hour data with PIMUN
Oxidative Stress Marker Levels
Time frame: baseline versus after 48- hour using PIMUN
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain NIRS, Polysomnogram and Reactive oxydative species in people with Preterm and Apnea of Prematurity, run by Pontificia Universidad Catolica de Chile at 2 sites in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paulina A Toso, MD (56223543349 ext. 3349, ptoso@med.puc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Time of Oxygen Saturation <90% (time frame: 48-hour data baseline versus 48- hour data with PIMUN). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.