NCT03448640

Efficacy of Mydriatic Drops in Premature Infants

Efficiency and Safety of Phenylephrine and Tropicamide Used in Premature Retinopathy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Bulent Ecevit University · Academic / Other
• Sex: All
• Age: 32 Weeks – 34 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Retinopathy of Prematurity

Interventions

Type	Name	Description
DRUG	Drug used in the examination of premature infants.	to investigate side effects of eye drops used

Timeline

• Start date: 2016-01-15
• Primary completion: 2017-10-15
• Completion: 2017-12-15
• First posted: 2018-02-28
• Last updated: 2018-02-28