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

Primary Purpose

Neonatal Disorder

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Tissue Oxygenation Monitoring

About this trial

This is an interventional device feasibility trial for Neonatal Disorder

Eligibility Criteria

undefined - 35 Weeks (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Universitätsspital Zürich

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CTOM

Arm Description

Outcomes

Primary Outcome Measures

Feasibility of aStO2 measurements in all patients

aStO2 values calculated with and without considering the presence of additional absorbers besides haemoglobin.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03706976

First Posted

October 10, 2018

Last Updated

December 19, 2022

Sponsor

Carag AG

1. Study Identification

Unique Protocol Identification Number

NCT03706976

Brief Title

NIRS to Monitor Abdominal Tissue Oxygen Saturation in Preterm Infants

Acronym

CTOM-FIH

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

April 30, 2019 (Actual)

Primary Completion Date

November 17, 2022 (Actual)

Study Completion Date

November 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Carag AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neonatal Disorder

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CTOM

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Tissue Oxygenation Monitoring

Intervention Description

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.

Primary Outcome Measure Information:

Title

Feasibility of aStO2 measurements in all patients

Description

aStO2 values calculated with and without considering the presence of additional absorbers besides haemoglobin.

Time Frame

72 hours

Secondary Outcome Measure Information:

Title

Safety of the investigational device assessed by evaluation of adverse events

Description

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.

Time Frame

72 hours

10. Eligibility

Sex

All

Maximum Age & Unit of Time

35 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Universitätsspital Zürich

City

Zürich

State/Province

ZIP/Postal Code

8091

Country

Switzerland

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

NIRS to Monitor Abdominal Tissue Oxygen Saturation in Preterm Infants

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