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Changes in Vital Signs and Pupil Diameter Related to Pharmacologic Mydriasis in Premature Infants: A Randomized Double Blind Clinical Study

NCT04838665 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-04-09

No results posted yet for this study

Summary

Retinopathy of prematurity (ROP) is one of the common anatomic causes of blindness among Filipinos, accounting for 47.7% of the cases. With this retinopathy being preventable and treatable, ROP screening has been proven to be effective in preventing blindness, which is achieved with the usage of mydriatics. Even if the regimen of multiple alternate instillations of 0.5% tropicamide and 2.5% phenylephrine is the one recommended by international guidelines for ROP screening, the mydriatic regimen used by many of the country's institutions is the single instillation of 0.5% tropicamide + 0.5% phenylephrine applied via a cotton wick placed in the inferior fornix (SIW). There have been no studies yet on the safety and efficacy in premature infants of this mydriatic preparation and method, although it is hypothesized that the usage of a cotton wick promotes the possible systemic effects of the mydriatic combination used.

This study then aims to determine the safety and efficacy of different mydriatic regimens in premature infants referred for screening of ROP using (1) multiple alternate instillations of 0.5% cyclopentolate hydrochloride and 2.5% phenylephrine (MAI), (2) single instillation of 0.5% tropicamide + 0.5% phenylephrine (SI), and (3) single instillation of 0.5% tropicamide + 0.5% phenylephrine with a cotton wick placed in the inferior fornix (SIW) in a tertiary Philippine hospital.

This study was designed as a randomized, double blind, clinical study which enrolled sixty preterm infants referred for ROP Screening from January to July 2011. With instillations via MAI, SI, and SIW, systolic blood pressure (SBP), diastolic pressure (DBP), mean arterial pressure (MAP), heart rate, and oxygen saturation were monitored from ten minutes prior to instillation up to forty-five minutes after instillation. Pupil dilations were also measured at the forty-fifth minute.

Conditions

  • Retinopathy of Prematurity

Interventions

DRUG

0.5% cyclopentolate and 2.5% phenylephrine

Multiple Alternate Instillation of 0.5% cyclopentolate and 2.5% phenylephrine (MAI) dropped every 5 minutes for two doses

DRUG

0.5% tropicamide + 0.5% phenylephrine

Single instillation of 0.5% tropicamide + 0.5% phenylephrine

DRUG

0.5% tropicamide + 0.5% phenylephrine with a cotton wick

Single instillation of 0.5% tropicamide + 0.5% phenylephrine with a cotton wick weighing 0.02 milligrams placed in the inferior fornix for the entire 45 minutes

Sponsors & Collaborators

  • University of the Philippines

    lead OTHER

Principal Investigators

  • Roland Joseph D Tan, MD · University of the Philippines Manila

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Week
Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2011-09-30
Completion
2011-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04838665 on ClinicalTrials.gov