NIRS to Monitor Abdominal Tissue Oxygen Saturation in Preterm Infants

NCT03706976 | Completed

• 1 other identifier: 2018.7557
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Disorder

Outcome Measures

Primary Outcomes (1)

• Feasibility of aStO2 measurements in all patients

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

  72 hours

Secondary Outcomes (1)

• Safety of the investigational device assessed by evaluation of adverse events

  72 hours

Study Arms (1)

CTOM

EXPERIMENTAL

Device: Tissue Oxygenation Monitoring

Interventions

Tissue Oxygenation Monitoring DEVICE

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.

CTOM

Eligibility Criteria

• Age: Up to 35 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Injured, hypersensitive or bruised skin present on the belly,
• 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.

Sponsors & Collaborators

• Carag AG: lead

Study Sites (1)

Universitätsspital Zürich

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Infant, Newborn, Diseases

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 16, 2018
• Study Start: April 30, 2019
• Primary Completion: November 17, 2022
• Study Completion: November 17, 2022
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)