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

NCT04838665 | Completed Phase 4

• 1 other identifier: OVS 2010-08-10-109
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (6)

• Systolic blood pressure and systolic blood pressure changes

  Measured in mmHg using a well-fitted neonatal cuff placed in the arm connected to the newly calibrated Phillips Digital IntelliVue MP20 junior Cardiac monitors

  A baseline systolic blood pressure determination was performed 10 and 5 minute prior to the first drop of mydriatic or proparacaine prior to packing. Additional reading will be done if there is significant difference in the v/s between 10 and 5 minutes

• Diastolic blood pressure and diastolic blood pressure changes

  Measured in mmHg using a well-fitted neonatal cuff placed in the arm connected to the newly calibrated Phillips Digital IntelliVue MP20 junior Cardiac monitors

  A baseline diastolic blood pressure determination was performed 10 and 5 minutes prior to the first drop of mydriatic or proparacaine prior to packing. Additional reading will be done if there is significant difference in the vital signs between 10 and 5

• Mean arterial blood pressure and mean arterial blood pressure changes

  Measured in mmHg using the newly calibrated Phillips Digital IntelliVue MP20 junior Cardiac monitors

  A baseline mean arterial blood pressure determination was performed 10 and 5 mins. prior to the first drop of mydriatic or proparacaine prior to packing. Additional reading will be done if there is significant difference in the vital signs between 10 an

• Heart rate

  Measured in beats per minute using the newly calibrated Phillips Digital IntelliVue MP20 junior Cardiac monitors

  A baseline heart rate determination was performed 10 and 5 minutes prior to the first drop of mydriatic or proparacaine prior to packing. Additional reading will be done if there is significant difference in the vital signs between 10 and 5 minutes prior

• Oxygen saturation

  Measured in percent saturation using a pulse oximeter connected to the newly calibrated Phillips Digital IntelliVue MP20 junior Cardiac monitors

  A baseline heart rate determination was performed 10 and 5 minutes prior to the first drop of mydriatic or proparacaine prior to packing. Additional reading will be done if there is significant difference in the vital signs between 10 and 5 minutes prior

• Pupil diameter

  Measuring using a digital camera and a millimeter ruler

  Measured at the 45th minute post-instillation of the specified intervention

Secondary Outcomes (1)

• Successful retinopathy of prematurity screening

  After the 45th minute measurement of pupil diameter

Study Arms (3)

Multiple Alternate Instillation of 0.5% cyclopentolate and 2.5% phenylephrine (MAI)

ACTIVE COMPARATOR

20 infants were enrolled in Multiple Alternate Instillation of 0.5% cyclopentolate and 2.5% phenylephrine (MAI)

Drug: 0.5% cyclopentolate and 2.5% phenylephrine; Drug: 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 (SI)

EXPERIMENTAL

Single instillation of 0.5% tropicamide + 0.5% phenylephrine (SI)

Drug: 0.5% cyclopentolate and 2.5% phenylephrine; Drug: 0.5% tropicamide + 0.5% phenylephrine; Drug: 0.5% tropicamide + 0.5% phenylephrine with a cotton wick

1 instillation of 0.5% tropicamide +0.5% phenylephrine w/a cotton wick placed in the inferior fornix

EXPERIMENTAL

Single instillation of 0.5% tropicamide + 0.5% phenylephrine with a cotton wick placed in the inferior fornix (SIW)

Drug: 0.5% cyclopentolate and 2.5% phenylephrine; Drug: 0.5% tropicamide + 0.5% phenylephrine; Drug: 0.5% tropicamide + 0.5% phenylephrine with a cotton wick

Interventions

0.5% cyclopentolate and 2.5% phenylephrine DRUG

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

Also known as: Multiple Alternate Instillation of Cyclopentolate Hydrochloride Dilate® Micro Labs Limited Bangalore and Phenylephrine Hydrochloride Mydfrin™ 25mg/mL (2.5%) Alcon Fort Worth Texas

1 instillation of 0.5% tropicamide +0.5% phenylephrine w/a cotton wick placed in the inferior fornix; Multiple Alternate Instillation of 0.5% cyclopentolate and 2.5% phenylephrine (MAI); Single instillation of 0.5% tropicamide + 0.5% phenylephrine (SI)

0.5% tropicamide + 0.5% phenylephrine DRUG

Single instillation of 0.5% tropicamide + 0.5% phenylephrine

Also known as: Single instillation of Tropicamide + Phenylephrine Hydrochloride Sanmyd-P 0.5%/0.5% Santen Osaka Japan

1 instillation of 0.5% tropicamide +0.5% phenylephrine w/a cotton wick placed in the inferior fornix; Multiple Alternate Instillation of 0.5% cyclopentolate and 2.5% phenylephrine (MAI); Single instillation of 0.5% tropicamide + 0.5% phenylephrine (SI)

0.5% tropicamide + 0.5% phenylephrine with a cotton wick DRUG

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

Also known as: Single instillation of Tropicamide + Phenylephrine Hydrochloride Sanmyd-P 0.5%/0.5% Santen Osaka Japan with a cotton wick placed in the inferior fornix weighing 0.02 milligrams

1 instillation of 0.5% tropicamide +0.5% phenylephrine w/a cotton wick placed in the inferior fornix; Multiple Alternate Instillation of 0.5% cyclopentolate and 2.5% phenylephrine (MAI); Single instillation of 0.5% tropicamide + 0.5% phenylephrine (SI)

Eligibility Criteria

• Age: 1 Week - 32 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• birth weight of less than 1500 g
• gestational age of 32 weeks or less
• an unstable clinical course who are believed to be at high risk for Retinopathy of Prematurity, as assessed by their individual attendings

You may not qualify if:

• infants with cardiac abnormalities directly affecting the heart rate and oxygen saturation
• infants with inotropic medications
• infants with ventilatory support

Sponsors & Collaborators

• University of the Philippines: lead

MeSH Terms

Conditions

Retinopathy of Prematurity

Interventions

Cyclopentolate; Phenylephrine; Tropicamide

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Ethanolamines; Amino Alcohols; Alcohols; Amines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Roland Joseph D Tan, MD

  University of the Philippines Manila

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: April 9, 2021
• Study Start: September 30, 2011
• Primary Completion: September 30, 2011
• Study Completion: September 30, 2011
• Last Updated: April 9, 2021

Record last verified: 2021-04