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

NCT ID: NCT01305720

Last Updated: 2011-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-12-31

Brief Summary

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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

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

Conditions

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Prematurity of Fetus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

28 Days

Maximum Eligible Age

90 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zekai Tahir Burak Women's Health Research and Education Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zekai Tahir Burak Maternity and Teaching Hospital

Locations

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Zekai Tahir Burak Maternity and Teaching Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Hatice Tatar Aksoy, MD

Role: CONTACT

0905327114054

Ugur Dilmen, Prof.

Role: CONTACT

0903123065270

Facility Contacts

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Hatice Tatar Aksoy, MD

Role: primary

0905327114054

Other Identifiers

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734

Identifier Type: -

Identifier Source: org_study_id

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