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Efficacy of Mydriatic Drops in Premature Infants

B

Bulent Ecevit University

Status

Completed

Conditions

Retinopathy of Prematurity

Treatments

Drug: Drug used in the examination of premature infants.

Study type

Observational

Funder types

Other

Identifiers

NCT03448640
BulentEU

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

32 to 34 weeks old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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