Anemic Preterms, Cerebral Oxygenation,Somatic Oxygenation,Blood TransfusionNCT01251068
Measurement of Cerebral and Peripheric Tissue Oxygenation in Anemic Preterm Infants Who Underwent Blood Transfusion
A study testing near infrared spectroscopy: invos 5100, INVOS 5100 and near infrared spectroscopy device in people with Anemic Preterms, Cerebral Oxygenation,Somatic Oxygenation,Blood Transfusion, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 2 sites in Turkey (Türkiye).
Trial summary
Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside investigation of cerebral oxygenation in newborn infants. Using this technique we investigated the relationship between changes in cerebral oxygenation and hemodynamics, and changes in some physiological variables during blood… Read more about this study
- Who is it for?
- Ages 30 days and older
- Conditions the study is for
- Anemic Preterms, Cerebral Oxygenation,Somatic Oxygenation,Blood Transfusion
- What is being tested?
- near infrared spectroscopy: invos 5100, INVOS 5100 and near infrared spectroscopy device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Dec 2010to Jun 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 30 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Inclusion Criteria: <32 gestational age and/or <1500gr.,>30th day preterm infants -
Exclusion Criteria:sepsis,shock,severe intracranial hemorrhage,NEC,abdominal and cranial surgery
-
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Zekai Tahir Maternity Teaching Hospital
Ankara, Hamamönü, 06330
gonca sandal, MD, +905054871028, kocabasgonca@mynet.com
gonca sandal, MD
- Recruiting
Zekai Tahir Maternity Teaching Hospital
Ankara, Hamamönü, 06330
UGUR, DILMEN, +903125065270, ugurdilmen@gmail.com
gonca sandal, MD
About this study
Official title: Measurement of Cerebral and Peripheric Tissue Oxygenation in Anemic Preterm Infants Who Underwent Blood Transfusion:A Near Infrared Spectroscopy Study.
Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside investigation of cerebral oxygenation in newborn infants. Using this technique we investigated the relationship between changes in cerebral oxygenation and hemodynamics, and changes in some physiological variables during blood transfusion in anaemic preterm infants.
- Being tested
- near infrared spectroscopy: invos 5100, INVOS 5100, near infrared spectroscopy device
- Keywords
- anemic preterms, cerebral oxygenation,somatic oxygenation, blood transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
near infrared spectroscopy: invos 5100Device
duration:six hours
INVOS 5100Device
NIRS device used in this study, the optical field includes a volume of tissue approximately 2 cm deep to the surface probe with a 4-mm source-detector distance, and thus, organ-specific monitoring is feasible in small patients. With informed consent, we applied NIRS probes to the forehead and the lower extremity for cerebral (rSO2C) and peripheric (rSO2P) regional oxygen saturation measurements.
near infrared spectroscopy deviceDevice
NIRS device used in this study, the optical field includes a volume of tissue approximately 2 cm deep to the surface probe with a 4-mm source-detector distance, and thus, organ-specific monitoring is feasible in small patients. With informed consent, we applied NIRS probes to the forehead and the lower extremity for cerebral (rSO2C) and peripheric (rSO2P) regional oxygen saturation measurements.
| Study group | Role | What they receive |
|---|---|---|
| gest age, cerebral ,somatic oxygenation measurement | Experimental | Not described Receives: Device: near infrared spectroscopy: invos 5100; Device: INVOS 5100; Device: near infrared spectroscopy device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral and peripheric oxygenation measurements in anemic preterm infants.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemic Preterms, Cerebral Oxygenation,Somatic Oxygenation,Blood TransfusionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT01251068
- Sponsor's protocol ID
- 1
- Status last verified
- Nov 2010
- First submitted
- 30 Nov 2010
- Last updated
- 7 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Cerebral and Peripheric Tissue Oxygenation in Anemic Preterm Infants Who Underwent Blood Transfusion:A Near Infrared Spectroscopy Study.
- ClinicalTrials.gov ID
- NCT01251068
- Acronym / sponsor ID
- 1
- Keywords
- anemic preterms, cerebral oxygenation,somatic oxygenation, blood transfusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 1 Dec 2010 (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.
Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside investigation of cerebral oxygenation in newborn infants. Using this technique we investigated the relationship between changes in cerebral oxygenation and hemodynamics, and changes in some physiological variables during blood transfusion in anaemic preterm infants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gest age, cerebral ,somatic oxygenation measurement | Experimental | Device: near infrared spectroscopy: invos 5100, Device: INVOS 5100, Device: near infrared spectroscopy device |
Who may qualify
- Ages
- 30 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| near infrared spectroscopy: invos 5100duration:six hours | Device | gest age, cerebral ,somatic oxygenation measurement |
| INVOS 5100NIRS device used in this study, the optical field includes a volume of tissue approximately 2 cm deep to the surface probe with a 4-mm source-detector distance, and thus, organ-specific monitoring is feasible in small patients. With informed consent, we applied NIRS probes to the forehead and the lower extremity for cerebral (rSO2C) and peripheric (rSO2P) regional oxygen saturation measurements. | Device | gest age, cerebral ,somatic oxygenation measurement |
| near infrared spectroscopy deviceNIRS device used in this study, the optical field includes a volume of tissue approximately 2 cm deep to the surface probe with a 4-mm source-detector distance, and thus, organ-specific monitoring is feasible in small patients. With informed consent, we applied NIRS probes to the forehead and the lower extremity for cerebral (rSO2C) and peripheric (rSO2P) regional oxygen saturation measurements. | Device | gest age, cerebral ,somatic oxygenation measurement |
Primary outcome
Cerebral and peripheric oxygenation measurements in anemic preterm infants.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2010.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing near infrared spectroscopy: invos 5100, INVOS 5100 and near infrared spectroscopy device in people with Anemic Preterms, Cerebral Oxygenation,Somatic Oxygenation,Blood Transfusion, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 2 sites 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?
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 7 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 gonca sandal, MD (05054871028, kocabasgonca@mynet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral and peripheric oxygenation measurements in anemic preterm infants. (time frame: 6 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 7 Dec 2010.