NIRS to Monitor Abdominal Tissue Oxygen Saturation in Preterm Infants (CTOM-FIH)

NIRS to Monitor Abdominal Tissue Oxygen Saturation in Preterm Infants in an Open Mono-centric Study

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.

Study Overview

• Status: Completed
• Conditions: Neonatal Disorder
• Intervention / Treatment: Device: Tissue Oxygenation Monitoring

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • ZH
    • Zürich, ZH, Switzerland, 8091
      • Universitätsspital Zürich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Preterm infants with GA less than 35 0/7 weeks
• Start of measurement earliest at day of life 2 for preterm infants with GA >=30 0/7 weeks and day of life 4 otherwise. The measurement will not start after day of life 5 for all GA.
• Signed Informed consent of the legal representative(s) is received after being informed. It is sufficient, if the consent form is signed by one legal representative, which is in majority of cases either the mother or the father.
• Clinically stable condition. The clinical stability is to be reconfirmed before the start and checked during the measurement.

Exclusion Criteria:

• Injured, hypersensitive or bruised skin present on the belly,
• Existence of clinical instability at any time during the investigation leads to exclusion, if ordered so by the physician entrusted with the investigation,
• Any medical care equipment, e.g. patches, dressing, umbilical arterial or venous catheter, blood supply, etc., prohibiting correct placement of the sensors,
• Dark skin pigmentation or dense hairiness on the belly absorbing too much light in the near infrared region to allow for NIRS,
• Congenital malformations,
• Severe metabolic disorders,
• Early onset sepsis,
• Inability of legal representatives to understand the purpose of the clinical trial due to language barriers such as the insufficient ability to understand the spoken or written language,
• The treatment of newborn jaundice with light during the intended measurement time,
• Previous enrolment into the current study,
• Family members, employees and other dependent persons of the investigator,
• Participation in another study with investigational drug/device within the preceding days and during the present study which may influence aStO2.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CTOM

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of aStO2 measurements in all patients	aStO2 values calculated with and without considering the presence of additional absorbers besides haemoglobin.	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of the investigational device assessed by evaluation of adverse events	Evaluation of AEs (Adverse Event) with regard to the investigational device. The safety related to application and use of the NIRS sensors is aimed for.	72 hours

Collaborators and Investigators

• Sponsor: Carag AG

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2019
• Primary Completion (Actual): November 17, 2022
• Study Completion (Actual): November 17, 2022

Study Registration Dates

• First Submitted: October 10, 2018
• First Submitted That Met QC Criteria: October 12, 2018
• First Posted (Actual): October 16, 2018

Study Record Updates

• Last Update Posted (Estimate): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infant, Newborn, Diseases
• Other Study ID Numbers: 2018.7557

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No