MedTrace Logo

NIRS to Monitor Abdominal Tissue Oxygen Saturation in Preterm Infants

NCT03706976 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-12-20

No results posted yet for this study

Summary

The NIRS (near infrared spectroscopy) sensor will be applied to the abdomen of the study population. To ensure good skin contact the sensor will be placed underneath the diaper. If that should not provide enough measurement stability, additional fixation will be given by employing aforementioned flexible bandage routinely employed in neonatal care. Once good skin contact is ensured, the sensor will measure aStO2 (abdominal tissue oxygen saturation) for up to seventy-two hours. The presence of this sensor will not disturb daily clinical activities or medical treatment in any way. Should good skin contact be endangered by movements, clinical interactions or such, the sensor will be removed and re-attached to the infants' abdomen as a consequence.

Conditions

  • Neonatal Disorder

Interventions

DEVICE

Tissue Oxygenation Monitoring

The NIRS sensor will be applied to the abdomen of the study population. To ensure good skin contact the sensor will be placed underneath the diaper. If that should not provide enough measurement stability, additional fixation will be given by employing aforementioned flexible bandage routinely employed in neonatal care. Once good skin contact is ensured, the sensor will measure aStO2 for up to seventy-two hours. The presence of this sensor will not disturb daily clinical activities or medical treatment in any way. Should good skin contact be endangered by movements, clinical interactions or such, the sensor will be removed and re-attached to the infants' abdomen as a consequence.

Sponsors & Collaborators

  • Carag AG

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
35 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-30
Primary Completion
2022-11-17
Completion
2022-11-17

Countries

  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03706976 on ClinicalTrials.gov