Actively Recruiting
Clinical Study of Intermittent Hypoxia Reduction Using PIMUN in Preterm Infants with Apnea of Prematurity
Led by Pontificia Universidad Catolica de Chile · Updated on 2026-02-09
20
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
P
Pontificia Universidad Catolica de Chile
Lead Sponsor
A
Agencia Nacional de Investigación y Desarrollo
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying whether the PIMUN medical device can reduce intermittent hypoxemia in preterm infants born between 24 and 34 weeks of gestational age. This trial focuses on babies younger than 30 days with apnea of prematurity. The study aims to find out if PIMUN lowers the time oxygen levels drop below 90% and to evaluate its safety during use. Participants will be randomly assigned to use PIMUN or receive usual care without PIMUN for 48 hours in a crossover design. PIMUN is a soft garment with an inflatable dorsal chamber that delivers pulsatile stimulation to encourage breathing. During each 48-hour period, infants will have continuous heart and breathing monitoring, brain oxygen level checks by near-infrared spectroscopy, and 4 to 5 hours of sleep studies. Blood and urine samples will be collected to measure oxidative stress. Throughout the trial, researchers will monitor oxygen saturation, heart rate, apnea events, sleep quality, and safety indicators like skin condition and comfort. They will compare outcomes between periods with and without PIMUN. The main measurement is total time with oxygen saturation under 90%. The study also tracks deeper oxygen drops, apnea numbers, and need for breathing support. Participation lasts through both 48-hour intervention periods with monitoring and sample collection.
CONDITIONS
Brief Title
Efficacy of PIMUN by Reducing Intermittent Hypoxia Events
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Preterm infants born before 34 weeks of gestation
- Younger than 30 days at enrollment
- Diagnosed with apnea of prematurity (AOP)
You will not qualify if you...
- Currently receiving mechanical ventilation
- Major congenital malformations present
- Clinically unstable or critically ill at screening
- Active sepsis or under treatment for sepsis
- Intraventricular hemorrhage grade higher than II
- Receiving sedatives or anticonvulsant medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants must be preterm infants born before 34 weeks of gestation, younger than 30 days, and diagnosed with apnea of prematurity. Exclusions include mechanical ventilation, major malformations, critical illness, sepsis, severe hemorrhage, or certain medications.
Duration - Two 48-hour periods separated by a washout period
Participants undergo two 48-hour intervention periods in randomized order: one with PIMUN dorsal stimulation and one without (sham). Continuous cardiorespiratory monitoring is performed throughout each period.
Continuous monitoring during each 48-hour period with Brain NIRS for the first 24 hours and 4-5 hours of polysomnogram recording on the second day. Blood and urine samples are collected at the end of each period.
Trial Site Locations
Total: 2 locations
1
Clinica San Carlos de Apoquindo
Santiago, Santiago Metropolitan, Chile
Active, Not Recruiting
2
UC Christus Clinical Hospital
Santiago, Santiago Metropolitan, Chile
Actively Recruiting
Research Team
P
Paulina A Toso, MD
A
Alvaro J González, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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