Neonatal DisorderCTOM-FIHNCT03706976
NIRS to Monitor Abdominal Tissue Oxygen Saturation in Preterm Infants
A study testing Tissue Oxygenation Monitoring in people with Neonatal Disorder, run by Carag AG at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 35 weeks
- Conditions the study is for
- Neonatal Disorder
- What is being tested?
- Tissue Oxygenation Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Apr 2019to 17 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 35 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Universitätsspital Zürich
Zurich, Canton of Zurich, 8091
About this study
Official title: 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.
- Conditions
- Neonatal Disorder
- Being tested
- Tissue Oxygenation Monitoring
- Medical subject headings
- Infant, Newborn, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue Oxygenation MonitoringDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CTOM | Experimental | Not described Receives: Device: Tissue Oxygenation Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of aStO2 measurements in all patients
aStO2 values calculated with and without considering the presence of additional absorbers besides haemoglobin.
Measured: 72 hours
Secondary outcomes (1)
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.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start30 Apr 2019
- Primary completion17 Nov 2022
- Study completion17 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carag AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706976
- Sponsor's protocol ID
- 2018.7557
- Acronym
- CTOM-FIH
- Status last verified
- Dec 2022
- First submitted
- 10 Oct 2018
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIRS to Monitor Abdominal Tissue Oxygen Saturation in Preterm Infants in an Open Mono-centric Study
- ClinicalTrials.gov ID
- NCT03706976
- Acronym / sponsor ID
- CTOM-FIH / 2018.7557
- Conditions
- Neonatal Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Carag AGIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 17 Nov 2022 (actual)
- Study completion
- 17 Nov 2022 (actual)
- First posted
- 16 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CTOM | Experimental | Device: Tissue Oxygenation Monitoring |
Who may qualify
- Ages
- Up to 35 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tissue Oxygenation MonitoringThe 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. | Device | CTOM |
Primary outcome
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.
1 secondary outcome
Safety of the investigational device assessed by evaluation of adverse events
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tissue Oxygenation Monitoring in people with Neonatal Disorder, run by Carag AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of aStO2 measurements in all patients (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.