search
Back to results

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

Primary Purpose

Prematurity of Fetus

Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
near infrared spectroscopy: invos 5100
Sponsored by
Zekai Tahir Burak Women's Health Research and Education Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prematurity of Fetus focused on measuring mydriatic, NIRS, preterm, eye drops, cerebral, mesenteric oxygenation

Eligibility Criteria

28 Days - 90 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zekai Tahir Burak Maternity and Teaching Hospital

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 28, 2011
Last Updated
February 28, 2011
Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01305720
Brief Title
The Effect of Mydriatic Eye Drops on Cerebral and Mesenteric Oxygenation in Preterm Infants
Official Title
The Effect of Mydriatic Eye Drops on Cerebral and Mesenteric Oxygenation in Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity of Fetus
Keywords
mydriatic, NIRS, preterm, eye drops, cerebral, mesenteric oxygenation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
near infrared spectroscopy: invos 5100
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Effect of Mydriatic Eye Drops on Cerebral and mesenteric Oxygenation
Description
By NIRS cerebral and mesenteric oxygenation will be measured before, during and after mydriatic eye drops are instilled.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Days
Maximum Age & Unit of Time
90 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: < 32 gestational age and/or < 1500gr. ≥ 28th day preterm infants Instilled mydriatic eye drops for ROP examination Exclusion Criteria: Sepsis Shock Severe intracranial hemorrhage NEC Abdominal and cranial surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hatice Tatar Aksoy, MD
Phone
0905327114054
Email
haticetatar@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ugur Dilmen, Prof.
Phone
0903123065270
Email
ugurdilmen@gmail.com
Facility Information:
Facility Name
Zekai Tahir Burak Maternity and Teaching Hospital
City
Ankara
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hatice Tatar Aksoy, MD
Phone
0905327114054
Email
haticetatar@yahoo.com
First Name & Middle Initial & Last Name & Degree
Hatice Tatar Aksoy, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs