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The Effect of Mydriatic Eye Drops on Cerebral and Mesenteric Oxygenation in Preterm Infants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Zekai Tahir Burak Maternity and Teaching Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier:
NCT01305720
First received: February 28, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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


Condition Intervention Phase
Prematurity of Fetus
 Device: near infrared spectroscopy: invos 5100
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Effect of Mydriatic Eye Drops on Cerebral and Mesenteric Oxygenation in Preterm Infants

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies
U.S. FDA Resources

Further study details as provided by Zekai Tahir Burak Maternity and Teaching Hospital:

Primary Outcome Measures:
  • The Effect of Mydriatic Eye Drops on Cerebral and mesenteric Oxygenation [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    By NIRS cerebral and mesenteric oxygenation will be measured before, during and after mydriatic eye drops are instilled.


Estimated Enrollment: 30
Study Start Date: March 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: near infrared spectroscopy: 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, the investigators applied NIRS probes to the forehead and abdomen for cerebral (rSO2C) and abdominal (rSO2P) regional oxygen saturation measurements.
Detailed Description:

The cerebral and mesenteric oxygenation will be measured by NIRS before, during and after the mydriatic eye drops are instilled.

  Eligibility

Ages Eligible for Study:   up to 90 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. < 32 gestational age and/or < 1500gr.
  2. ≥ 28th day preterm infants
  3. Instilled mydriatic eye drops for ROP examination

Exclusion Criteria:

  1. Sepsis
  2. Shock
  3. Severe intracranial hemorrhage
  4. NEC
  5. Abdominal and cranial surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01305720

Contacts
Contact: Hatice Tatar Aksoy, MD 0905327114054 haticetatar@yahoo.com
Contact: Ugur Dilmen, Prof. 0903123065270 ugurdilmen@gmail.com

Locations
Turkey
Zekai Tahir Burak Maternity and Teaching Hospital Not yet recruiting
Ankara, Turkey
Contact: Hatice Tatar Aksoy, MD     0905327114054     haticetatar@yahoo.com    
Principal Investigator: Hatice Tatar Aksoy, MD            
Sponsors and Collaborators
Zekai Tahir Burak Maternity and Teaching Hospital
  More Information

No publications provided

Responsible Party: Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier: NCT01305720     History of Changes
Other Study ID Numbers: 734
Study First Received: February 28, 2011
Last Updated: February 28, 2011
Health Authority: Turkey: Ethics Committee

Keywords provided by Zekai Tahir Burak Maternity and Teaching Hospital:
mydriatic
NIRS
preterm
 eye drops
cerebral
mesenteric oxygenation

Additional relevant MeSH terms:
Tetrahydrozoline
Mydriatics
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
 Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013