pOSitional Changes of Premature InfantsPhase 4NCT01255189

Measurement of the Effect of Positional Changes on Cerebral Oxygenation in Preterm Infants

A Phase 4 study testing Device: near infrared spectroscopy: INVOS 5100 and invos 5100 in people with pOSitional Changes of Premature Infants, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 effect of positional changes on cerebral oxygenation in preterm infants. Read more about this study

Who is it for?: Ages 3 days to 2 months
Conditions the study is for: pOSitional Changes of Premature Infants
What is being tested?: Device: near infrared spectroscopy: INVOS 5100 and invos 5100
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteTurkey (Türkiye)
Study dates: Dec 2010to Jun 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 3 days to 2 months
All sexes
No healthy volunteers
Child

Who may be able to join

<32 gestational age and/or <1500gr.
>30th day preterm infants

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

Gamze Demirel
Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: Measurement of the Effect of Positional Changes on Cerebral Oxygenation in Preterm Infants: A Near Infrared Spectroscopy Study

Read the detailed description

The changes in cerebral perfusion have an important role on the development of intraventricular hemorrhage and periventricular leucomalacia. Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside investigation of cerebral oxygenation in newborn infants. Using this technique we investigated the effect of positional changes on cerebral oxygenation in preterm infants.

Conditions: pOSitional Changes of Premature Infants
Being tested: Device: near infrared spectroscopy: INVOS 5100, invos 5100
Keywords: NIRS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Device: near infrared spectroscopy: INVOS 5100Device
Also called invos 5100
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.
invos 5100Device
near infrared spectroscopy: invos 5100

Study groups in NCT01255189
Study group	Role	What they receive
Device: near infrared spectroscopy: invos 5100	Experimental	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 Receives: Device: Device: near infrared spectroscopy: INVOS 5100; Device: invos 5100

What is being measured

The primary outcome is the main question the study is designed to answer.

The effect of positional changes on cerebral oxygenation in 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.

Dec 2010Jun 2011

First posted7 Dec 2010 (estimated)
Study startDec 2010
Primary completionJun 2011
Study completionJun 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for pOSitional Changes of Premature InfantsStudies 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01255189
Sponsor's protocol ID: 3498
Status last verified: Dec 2010
First submitted: 2 Dec 2010
Last updated: 9 Aug 2011
Results posted: No
Data monitoring committee: No

Publications

Demirel G, Oguz SS, Celik IH, Erdeve O, Dilmen U. Cerebral and mesenteric tissue oxygenation by positional changes in very low birth weight premature infants. Early Hum Dev. 2012 Jun;88(6):409-11. doi: 10.1016/j.earlhumdev.2011.10.005. Epub 2011 Nov 15.
PubMed 22088784

Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Measurement of the Effect of Positional Changes on Cerebral Oxygenation in Preterm Infants: A Near Infrared Spectroscopy Study
ClinicalTrials.gov ID: NCT01255189
Acronym / sponsor ID: 3498
Conditions: pOSitional Changes of Premature Infants
Keywords: NIRS
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 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 (actual)
Study completion: Jun 2011 (actual)
First posted: 7 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.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Device: near infrared spectroscopy: invos 5100	Experimental	Device: Device: near infrared spectroscopy: INVOS 5100, Device: 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

Who may qualify

Ages: 3 days to 2 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

<32 gestational age and/or <1500gr.
>30th day preterm infants

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
Device: near infrared spectroscopy: INVOS 5100Also: 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	Device: near infrared spectroscopy: invos 5100
invos 5100near infrared spectroscopy: invos 5100	Device	Device: near infrared spectroscopy: invos 5100

Primary outcome

The effect of positional changes on cerebral oxygenation in preterm infants
Time frame: 6 months

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 9 Aug 2011.
Derived from this study: PubMed 22088784Demirel G, Oguz SS, Celik IH, Erdeve O, Dilmen U. Cerebral and mesenteric tissue oxygenation by positional changes in very low birth weight premature infants. Early Hum Dev. 2012 Jun;88(6):409-11. doi: 10.1016/j.earlhumdev.2011.10.005. Epub 2011 Nov 15.

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?

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 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: finished, as of the sponsor's last update on 9 Aug 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?

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?

The effect of positional changes on cerebral oxygenation in 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?

On the ClinicalTrials.gov record for NCT01255189, which also lists 1 linked publication.

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 9 Aug 2011.