PIMUN to reduce low-oxygen episodes in preterm infants
Official title: Clinical Study of Intermittent Hypoxia Reduction Using PIMUN: Efficacy Proof-of-Concept
Run by Pontificia Universidad Catolica de Chile · NCT07396103 · Data updated 2026-11-12
We will test whether PIMUN, a soft garment that gives gentle pulsatile dorsal stimulation, can reduce low-oxygen (SpO2 <90%) episodes in preterm infants born at 24–34 weeks who have apnea of prematurity.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 30 Days |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Pontificia Universidad Catolica de Chile Academic / other |
| Locations | 2 sites (Santiago, Santiago Metropolitan and 1 other locations) |
| Status | Recruiting |
| Started | September 1, 2024 |
| Main results expected | May 30, 2026 |
| Study ends | May 31, 2026 |
| Registry record updated | February 9, 2026 |
| Trial ID | NCT07396103 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are preterm infants born before 34 weeks, less than 30 days old at enrollment, with a documented diagnosis of apnea of prematurity who are clinically stable and not mechanically ventilated.
✕Probably not a fit
Infants who are mechanically ventilated, clinically unstable, have major congenital malformations or high-grade intraventricular hemorrhage, active sepsis, or are receiving sedatives/anticonvulsants are unlikely to benefit or be eligible for this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a pilot randomized crossover study in which preterm infants will be randomly assigned to 48 hours with PIMUN stimulation and 48 hours with usual care, in alternating order. Continuous monitoring will capture regional brain oxygenation with near-infrared spectroscopy (NIRS) on the first day of each period and 4–6 hours of polysomnography on the second day. Blood and urine samples for oxidative stress markers will be collected at the end of each 48-hour period, and safety events will be recorded throughout. The primary outcome is total duration of oxygen saturation below 90%, with secondary analyses of deeper desaturations and device-related adverse events.
Why it matters
Potential benefit: If successful, PIMUN could reduce the time preterm infants spend with low oxygen levels and potentially lower short- and long-term complications related to intermittent hypoxia.
How similar studies have gone: Prior small clinical studies of mechanized dorsal or extremity stimulation have reduced apnea counts and time with low oxygen, but PIMUN is a novel device applying an optimized pulsatile dorsal stimulation protocol.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
UC Christus Clinical Hospital
Santiago, Santiago Metropolitan, Chile Recruiting -
Clinica San Carlos de Apoquindo
Santiago, Santiago Metropolitan, Chile Active not recruiting
Study contacts
- Study coordinator: Paulina A Toso, MD
- Email: ptoso@med.puc.cl
- Phone: 56223543349
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.