HYPERNATREMIANCT01299428
Evaluation of the Cerebral Oxygenation With Near Infrared Spectrophotometry (NIRS) at the Hypernatremic Dehydration in Newborn
A study testing INVOS 5100 in people with HYPERNATREMIA, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to evaluate cerebral oxygenation with Near infrared spectrophotometry (NIRS) at the hypernatremic dehydration in newborns. Read more about this study
- Who is it for?
- Ages 1 day to 1 month
- Conditions the study is for
- HYPERNATREMIA
- What is being tested?
- INVOS 5100
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2011to Aug 2011
- 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 1 day to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- gestation week > 37 ve Na >150 mg/dl
- Dehydration
Who cannot join
- Sepsis
- Intracranial Haemorrhagia
- Congenital Cardiac Diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Zekai Tahir Burak Maternity Teaching Hospital
Ankara, Samanpazarı, 06460
melek akar, M.D., +905052550518, melek_akar@yahoo.com.tr
About this study
The aim of the study is to evaluate cerebral oxygenation with Near infrared spectrophotometry (NIRS) at the hypernatremic dehydration in newborns.
- Conditions
- HYPERNATREMIA
- Being tested
- INVOS 5100
- Keywords
- CEREBRAL OXYGENATION, HYPERNATREMİA, NEWBORN, NA VALUES
- Medical subject headings
- Hypernatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INVOS 5100Device
INVOS 5100 IS AN EQUIPMENT THAT MEASURED CEREBRAL OXYGENATION WITH NEAR INFRARED SPECTROPHOTOMETRY METHOD.
| Study group | Role | What they receive |
|---|---|---|
| cerebral oxygenation | Active comparator | Not described Receives: Device: INVOS 5100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
CEREBRAL OXYGENATION
NIRS METHODS
Measured: 3 MONTHS
Secondary outcomes (1)
NEURODEVELOPMENT
NEURODEVELOPMENT EVALUATION
Measured: 12-18 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionMay 2011 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HYPERNATREMIAStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299428
- Sponsor's protocol ID
- 5
- Status last verified
- Feb 2011
- First submitted
- 17 Feb 2011
- Last updated
- 18 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Cerebral Oxygenation With Near Infrared Spectrophotometry (NIRS) at the Hypernatremic Dehydration in Newborn
- ClinicalTrials.gov ID
- NCT01299428
- Acronym / sponsor ID
- 5
- Conditions
- HYPERNATREMIA
- Keywords
- CEREBRAL OXYGENATION, HYPERNATREMİA, NEWBORN, NA VALUES
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- May 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 18 Feb 2011 (estimated)
- 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 aim of the study is to evaluate cerebral oxygenation with Near infrared spectrophotometry (NIRS) at the hypernatremic dehydration in newborns.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cerebral oxygenation | Active comparator | Device: INVOS 5100 |
Who may qualify
- Ages
- 1 day to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- gestation week > 37 ve Na >150 mg/dl
- Dehydration
Key exclusion criteria (3 listed)
- Sepsis
- Intracranial Haemorrhagia
- Congenital Cardiac Diseases
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 |
|---|---|---|
| INVOS 5100INVOS 5100 IS AN EQUIPMENT THAT MEASURED CEREBRAL OXYGENATION WITH NEAR INFRARED SPECTROPHOTOMETRY METHOD. | Device | cerebral oxygenation |
Primary outcome
CEREBRAL OXYGENATION
Time frame: 3 MONTHS
NIRS METHODS
1 secondary outcome
NEURODEVELOPMENT
Time frame: 12-18 MONTHS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INVOS 5100 in people with HYPERNATREMIA, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Feb 2011. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact melek akar, M.D (+905052550518, melek_akar@yahoo.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CEREBRAL OXYGENATION (time frame: 3 MONTHS). 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 18 Feb 2011.