Efficacy of PIMUN by Reducing Intermittent Hypoxia Events

NCT07396103 | Recruiting DMC

• 1 other identifier: 210406008-3
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Preterm; Apnea of Prematurity; Hypoxemia

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (8)

• Total Time of Oxygen Saturation <85% and <80%

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

• Neonatal infant pain scale (NIPS)

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

• Total Time of Heart Rate <100 bpm

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

• Number of Apnea Events (Central, Mixed, or Obstructive)

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

• Duration of Desaturation Episodes

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

Other Outcomes (1)

• Number and type of Safety Events

  During each 48-hour intervention period

Study Arms (2)

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.

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.

Other: Brain NIRS; Other: Polysomnogram; Other: Reactive oxydative species

Interventions

Brain NIRS OTHER

24 hours of Brain regional oxygen saturation by NIRS

48 hours without PIMUN; PIMUN

Polysomnogram OTHER

4-5 hours of polysomnogram recording

48 hours without PIMUN; PIMUN

Reactive oxydative species OTHER

Blood and urine samples to detect plasma not albumin bound proteins- neuroprostane and isoflurane

48 hours without PIMUN; PIMUN

Eligibility Criteria

• Age: Up to 30 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead
• Agencia Nacional de Investigación y Desarrollo: collaborator

Study Sites (2)

Clinica San Carlos de Apoquindo

Santiago, Santiago Metropolitan, Chile

ACTIVE NOT RECRUITING

UC Christus Clinical Hospital

Santiago, Santiago Metropolitan, Chile

RECRUITING

MeSH Terms

Conditions

Premature Birth; Apnea; Hypoxia

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Paulina A Toso, MD

CONTACT

56223543349; ptoso@med.puc.cl

Alvaro J González, MD

CONTACT

56223543224; alvgonza@med.puc.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blinded to the origin of each intervention
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: experimental, randomized, crossover, not blinded, pilot study

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: February 9, 2026
• Study Start: September 1, 2024
• Primary Completion: May 30, 2026
• Study Completion: May 31, 2026
• Last Updated: February 9, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CL (2)