Prematurity of FetusPhase 4NCT01305720
The Effect of Mydriatic Eye Drops on Cerebral and Mesenteric Oxygenation in Preterm Infants
A Phase 4 study testing near infrared spectroscopy: invos 5100 in people with Prematurity of Fetus, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside investigation of cerebral and mesenteric oxygenation in newborn infants. Using this technique the investigators investigated the effect of mydriatic eye drops on cerebral and mesenteric oxygenation in preterm infants Read more about this study
- Who is it for?
- Ages 28 to 90 days
- Conditions the study is for
- Prematurity of Fetus
- What is being tested?
- near infrared spectroscopy: invos 5100
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2011to Dec 2011
- Phase
- Phase 4
- 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 28 to 90 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- < 32 gestational age and/or < 1500gr.
- ≥ 28th day preterm infants
- Instilled mydriatic eye drops for ROP examination
Who cannot join
- Sepsis
- Shock
- Severe intracranial hemorrhage
- NEC
- Abdominal and cranial surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zekai Tahir Burak Maternity and Teaching Hospital
Ankara
Hatice Tatar Aksoy, MD, 0905327114054, haticetatar@yahoo.com
Hatice Tatar Aksoy, MD
About this study
Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside investigation of cerebral and mesenteric oxygenation in newborn infants. Using this technique the investigators investigated the effect of mydriatic eye drops on cerebral and mesenteric oxygenation in preterm infants
Read the detailed description
The cerebral and mesenteric oxygenation will be measured by NIRS before, during and after the mydriatic eye drops are instilled.
- Conditions
- Prematurity of Fetus
- Being tested
- near infrared spectroscopy: invos 5100
- Keywords
- mydriatic, NIRS, preterm, eye drops, cerebral, mesenteric oxygenation
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
near infrared spectroscopy: 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, the investigators applied NIRS probes to the forehead and abdomen for cerebral (rSO2C) and abdominal (rSO2P) regional oxygen saturation measurements.
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of Mydriatic Eye Drops on Cerebral and mesenteric Oxygenation
By NIRS cerebral and mesenteric oxygenation will be measured before, during and after mydriatic eye drops are instilled.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prematurity of FetusStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT01305720
- Sponsor's protocol ID
- 734
- Status last verified
- Feb 2011
- First submitted
- 28 Feb 2011
- Last updated
- 1 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mydriatic Eye Drops on Cerebral and Mesenteric Oxygenation in Preterm Infants
- ClinicalTrials.gov ID
- NCT01305720
- Acronym / sponsor ID
- 734
- Conditions
- Prematurity of Fetus
- Keywords
- mydriatic, NIRS, preterm, eye drops, cerebral, mesenteric oxygenation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 1 Mar 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.
Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside investigation of cerebral and mesenteric oxygenation in newborn infants. Using this technique the investigators investigated the effect of mydriatic eye drops on cerebral and mesenteric oxygenation in preterm infants
Detailed description
The cerebral and mesenteric oxygenation will be measured by NIRS before, during and after the mydriatic eye drops are instilled.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 28 to 90 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- < 32 gestational age and/or < 1500gr.
- ≥ 28th day preterm infants
- Instilled mydriatic eye drops for ROP examination
Key exclusion criteria (5 listed)
- Sepsis
- Shock
- Severe intracranial hemorrhage
- NEC
- Abdominal and cranial surgery
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 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, the investigators applied NIRS probes to the forehead and abdomen for cerebral (rSO2C) and abdominal (rSO2P) regional oxygen saturation measurements. | Device | – |
Primary outcome
The Effect of Mydriatic Eye Drops on Cerebral and mesenteric Oxygenation
Time frame: one year
By NIRS cerebral and mesenteric oxygenation will be measured before, during and after mydriatic eye drops are instilled.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 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 Phase 4 study testing near infrared spectroscopy: invos 5100 in people with Prematurity of Fetus, 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 3 inclusion and 5 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 1 Mar 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hatice Tatar Aksoy, MD (0905327114054, haticetatar@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Effect of Mydriatic Eye Drops on Cerebral and mesenteric Oxygenation (time frame: one year). 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 1 Mar 2011.