Efficacy of Mydriatic Drops in Premature Infants

Completed

• Conditions: Retinopathy of Prematurity

• Registration Number: NCT03448640
• Lead Sponsor: Bulent Ecevit University

Brief Summary

Because of the neonatologists reported that some infants had suffered from vomiting, bradycardia, hypotonia, and aspiration risk about 30-60 minutes after the fundus examination in the intensive care unit. The investigators observed the pupil dilation effects and side effects of tipple instillation of phenylephrine 2.5% plus tropicamide 0.5% ophthalmic drop combination which the investigators routinely used in ROP examination.

Detailed Description

Purpose: To determine effect and vital change after topical application of phenylephrine 2.5% and tropicamide 0.5% three times for retinopathy of prematurity (ROP) examination in preterm infants.

Methods: Pupillary diameter, blood pressure, pulse rate, and oxygen saturation were monitored before, and after up to 24 hours 60 ROP screening examinations.

Study Timeline

• Study Start: 2016-01-15
• Primary Completion: 2017-10-15
• Study Completion: 2017-12-15
• Status Verified: 2018-02
• Study First Submitted: 2018-02-15
• Study First Submitted QC: 2018-02-27
• Last Update Submitted: 2018-02-27
• Study First Posted: 2018-02-28
• Last Update Posted: 2018-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Infants who were first ROP examinations
• infants born before 32 weeks.

Exclusion Criteria

• Developmental ocular and/or systemic anomalies.
• Drug use that can affect vital values
• Unstable general condition
• Food intolerance
• Recurrent vomiting.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The mean pupillary diameter	an average of 1 year	will be measured with a ruler after 60 minutes instillation of mydriatic