RecruitingNot Applicable

Efficacy of PIMUN by Reducing Intermittent Hypoxia Events

Chile20 participantsStarted 2024-09-01

Plain-language 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. 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.

Who can participate

Age range

30 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Total Time of Oxygen Saturation <90%

Timeframe: 48-hour data baseline versus 48- hour data with PIMUN

Trial details

NCT IDNCT07396103

SponsorPontificia Universidad Catolica de Chile

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-30

Contact for this trial

Paulina A Toso, MD

56223543349 ptoso@med.puc.cl

View on ClinicalTrials.gov More Preterm trials