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NCT01305720 Clinical Trial

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

Prematurity of Fetus Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01305720
Other study ID # 734
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received February 28, 2011
Last updated February 28, 2011
Start date March 2011
Est. completion date December 2011

Study information
Verified date February 2011
Source Zekai Tahir Burak Women's Health Research and Education Hospital
Contact Hatice Tatar Aksoy, MD
Phone 0905327114054
Email haticetatar@yahoo.com
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Interventional

Clinical 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

Description:

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 30
Est. completion date December 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group N/A to 90 Days
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Turkey Zekai Tahir Burak Maternity and Teaching Hospital Ankara

Sponsors (1)
Lead Sponsor Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. one year Yes
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