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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03706976
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : August 5, 2020
Sponsor:
Information provided by (Responsible Party):
Carag AG

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neonatal Disorder Device: Tissue Oxygenation Monitoring Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: NIRS to Monitor Abdominal Tissue Oxygen Saturation in Preterm Infants in an Open Mono-centric Study
Actual Study Start Date : April 30, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : December 2021

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.




Primary Outcome Measures :
  1. Feasibility of aStO2 measurements in all patients [ Time Frame: 72 hours ]
    aStO2 values calculated with and without considering the presence of additional absorbers besides haemoglobin.


Secondary Outcome Measures :
  1. Safety of the investigational device assessed by evaluation of adverse events [ Time Frame: 72 hours ]
    Evaluation of AEs with regard to the investigational device. The safety related to application and use of the NIRS sensors is aimed for.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 35 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706976


Contacts
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Contact: Jérôme Bernhard, MSc ETH 41417660202 jerome.bernhard@carag.com

Locations
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Switzerland
Universitätsspital Zürich Recruiting
Zürich, ZH, Switzerland, 8091
Sponsors and Collaborators
Carag AG
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Responsible Party: Carag AG
ClinicalTrials.gov Identifier: NCT03706976    
Other Study ID Numbers: 2018.7557
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infant, Newborn, Diseases