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

Phase 4

• Conditions: Prematurity of Fetus

• Registration Number: NCT01305720
• Lead Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital

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.

Study Timeline

• Status Verified: 2011-02
• Study First Submitted: 2011-02-28
• Study First Submitted QC: 2011-02-28
• Last Update Submitted: 2011-02-28
• Study Start: 2011-03
• Study First Posted: 2011-03-01
• Last Update Posted: 2011-03-01
• Primary Completion: 2011-06
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The Effect of Mydriatic Eye Drops on Cerebral and mesenteric Oxygenation	one year	By NIRS cerebral and mesenteric oxygenation will be measured before, during and after mydriatic eye drops are instilled.

Trial Locations

Locations (1)

Zekai Tahir Burak Maternity and Teaching Hospital; 🇹🇷 Ankara, Turkey