NCT07396103 Efficacy of PIMUN by Reducing Intermittent Hypoxia Events
| NCT ID | NCT07396103 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pontificia Universidad Catolica de Chile |
| Condition | Preterm |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2026-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-09-01 with a primary completion date of 2026-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07396103 clinical trial?
This trial is open to participants of all sexes, up to 30 Days, studying Preterm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07396103 currently recruiting?
Yes, NCT07396103 is actively recruiting participants. Contact the research team at ptoso@med.puc.cl for enrollment information.
Where is the NCT07396103 trial being conducted?
This trial is being conducted at Santiago, Chile, Santiago, Chile.
Who is sponsoring the NCT07396103 clinical trial?
NCT07396103 is sponsored by Pontificia Universidad Catolica de Chile. The trial plans to enroll 20 participants.