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The Effect of Eyemasks on Neonatal Stress Following Dilated Retinal Examination (MASK-ROP)

Primary Purpose

Retinopathy of Prematurity, Pain, Premature Infant

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Phototherapy Mask
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinopathy of Prematurity focused on measuring Retinopathy of Prematurity, ROP, Screening, Stress, Pain, Photophobia, Neonate, Light Sensitivity, Desaturation, Bradycardia, Apnea

Eligibility Criteria

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Inclusion Criteria:

  • Infant with birthweight of ≤1500 g or less or a gestational age of ≤ 32 weeks with no prior ROP screening. Examinations will be performed starting at either 4 weeks chronological age or 31 weeks post menstrual age, whichever is later.

Exclusion Criteria:

  • Pre-existing corneal abrasion/ulcers, ocular malformations that prevent dilation, and known neurological abnormalities that could affect response to pain.
  • Anticipation of transfer to another institution.
  • Prior ROP screening

Sites / Locations

  • Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care

Standard of Care + Phototherapy Mask

Arm Description

Infants in the control arm received standard examinations to screen for retinopathy of prematurity.

Infants in the treatment arm will have a standard phototherapy mask (Biliband, Natus, Pleasanton, California, USA) applied over the eyes after instillation of mydriatic drops. The masks will be removed 4 hours after the eye examination, when the pharmacologic effect of the mydriatic agents would have subsided. Infants will then receive standard examinations to screen for retinopathy of prematurity. The mask will be removed for the examination but reapplied promptly afterward.

Outcomes

Primary Outcome Measures

Number of all stressful events
Count of all desaturations, bradycardic events, and apneic events, adjusted for baseline rate of stressful events 12 hours prior to examination. Infants are under continuous vital sign monitoring and these events are flagged using the following parameters: Desaturation = Pulse oxymetry <88% Bradycardia = Heart rate <100bpm Apneic episode = Cessation of respiratory effort >20 seconds, or less if accompanied by bradycardia, cyanosis or pallor

Secondary Outcome Measures

Number of desaturations
Count of events 12 hours after examination, adjusted for baseline rate of events 12 hours prior to examination. Desaturation = Pulse oxymetry <88%.
Number of bradycardic events
Count of events 12 hours after examination, adjusted for baseline rate of events 12 hours prior to examination. Bradycardia = HR < 100bpm
Number of apneic events
Count of events 12 hours after examination, adjusted for baseline rate of events 12 hours prior to examination.
Heart Rate
Heart Rate (bpm) recorded every hour after the ROP exam
Respiratory Rate
Respiratory Rate (RPM) recorded every hour after the ROP exam
Oxygen saturation
Oxygen saturation (Oximetry %) recorded every hour after the ROP exam

Full Information

First Posted
January 21, 2019
Last Updated
January 29, 2019
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Unity Health Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT03824782
Brief Title
The Effect of Eyemasks on Neonatal Stress Following Dilated Retinal Examination
Acronym
MASK-ROP
Official Title
The Effect of Eyemasks on Neonatal Stress Following Dilated Retinal Examination, a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Unity Health Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Although screening exams for retinopathy of prematurity (ROP) prevent blindness they are physiologically stressful for infants. The investigators postulate that photosensitivity during mydriasis contributes to post-examination stress and that reducing light stimulation with a phototherapy mask can make infants more comfortable. The objective of this study is to determine the effect of a phototherapy mask worn during mydriasis on infant stress in the 12 hour period following ROP screening.
Detailed Description
Retinopathy of Prematurity (ROP) is a disorder of retinal vascular development of the low birthweight preterm infant that may lead to blindness if untreated. The long term visual acuity of infants with ROP detected by screening examination can be improved by peripheral retinal ablation therapy or injection of anti-VEGF agents. The screening examination for retinopathy of prematurity involves dilation with mydriatic eye drops, insertion of a lid speculum to retract the eyelids, and depression of the sclera to visualize the retina. These exams are routinely performed in Neonatal Intensive Care Units (NICUs) to facilitate early detection of ROP and guide treatment to prevent retinal detachment and blindness. However, infants undergoing this examination have shown elevations in heart rate, blood pressure, and desaturations at the time of the examination, and in the hours following. The frequency of apneic events experienced by these infants is increased in the 24-48 hour period after an examination. Several studies have looked at the pain response to mydriatic drops and speculum insertion as well as the systemic effects of the mydriatic drops. However, the cause of apneic events in the later post-examination period is unknown. The investigators postulate that photosensitivity related to mydriasis is distressing for infants in the period before and after the ROP exam, potentially contributing to stressful events, including apnea. The investigators propose to test this hypothesis by conducting a dual-centre, prospective parallel group trial with balanced randomization (1:1), applying a phototherapy mask (Biliband, Natus, Pleasanton, California, USA) to cover the eyes of the infant after the instillation of mydriatic drops, leaving the mask on for 4 hours, the typical duration of mydriasis following a drop of cyclopentolate. The investigators expect that this intervention will result in a significant reduction in the number of stressful events following an examination, and may reduce the amount of distress experienced by infants. Infants requiring ROP screening will be automatically identified as part of routine hospital protocols. Participants will be recruited from the NICUs at St. Michael's Hospital and Sunnybrook Health Sciences Hospital in Toronto, Ontario, Canada. The investigators predict that infants that have had their eyes shielded from environmental light while dilated are less likely to experience distressful events in the 12 hour period following ROP screening. If this study shows decreased rates of distress using this therapy, it would be a very simple addition to current practice and be of benefit for premature infants undergoing an uncomfortable exam.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinopathy of Prematurity, Pain, Premature Infant, Retinal Disease
Keywords
Retinopathy of Prematurity, ROP, Screening, Stress, Pain, Photophobia, Neonate, Light Sensitivity, Desaturation, Bradycardia, Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A dual-centre, prospective parallel group trial with balanced randomization (1:1) will be conducted.
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Infants in the control arm received standard examinations to screen for retinopathy of prematurity.
Arm Title
Standard of Care + Phototherapy Mask
Arm Type
Experimental
Arm Description
Infants in the treatment arm will have a standard phototherapy mask (Biliband, Natus, Pleasanton, California, USA) applied over the eyes after instillation of mydriatic drops. The masks will be removed 4 hours after the eye examination, when the pharmacologic effect of the mydriatic agents would have subsided. Infants will then receive standard examinations to screen for retinopathy of prematurity. The mask will be removed for the examination but reapplied promptly afterward.
Intervention Type
Device
Intervention Name(s)
Phototherapy Mask
Intervention Description
A standard phototherapy mask (Biliband, Natus, Pleasanton, California, USA) applied over the eyes after instillation of mydriatic drops. The masks will be removed 4 hours after the eye examination, when the pharmacologic effect of the mydriatic agents would have subsided.
Primary Outcome Measure Information:
Title
Number of all stressful events
Description
Count of all desaturations, bradycardic events, and apneic events, adjusted for baseline rate of stressful events 12 hours prior to examination. Infants are under continuous vital sign monitoring and these events are flagged using the following parameters: Desaturation = Pulse oxymetry <88% Bradycardia = Heart rate <100bpm Apneic episode = Cessation of respiratory effort >20 seconds, or less if accompanied by bradycardia, cyanosis or pallor
Time Frame
12 hours after examination
Secondary Outcome Measure Information:
Title
Number of desaturations
Description
Count of events 12 hours after examination, adjusted for baseline rate of events 12 hours prior to examination. Desaturation = Pulse oxymetry <88%.
Time Frame
12 hours
Title
Number of bradycardic events
Description
Count of events 12 hours after examination, adjusted for baseline rate of events 12 hours prior to examination. Bradycardia = HR < 100bpm
Time Frame
12 hours
Title
Number of apneic events
Description
Count of events 12 hours after examination, adjusted for baseline rate of events 12 hours prior to examination.
Time Frame
12 hours
Title
Heart Rate
Description
Heart Rate (bpm) recorded every hour after the ROP exam
Time Frame
4 hours
Title
Respiratory Rate
Description
Respiratory Rate (RPM) recorded every hour after the ROP exam
Time Frame
4 hours
Title
Oxygen saturation
Description
Oxygen saturation (Oximetry %) recorded every hour after the ROP exam
Time Frame
4 hours

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Infant with birthweight of ≤1500 g or less or a gestational age of ≤ 32 weeks with no prior ROP screening. Examinations will be performed starting at either 4 weeks chronological age or 31 weeks post menstrual age, whichever is later. Exclusion Criteria: Pre-existing corneal abrasion/ulcers, ocular malformations that prevent dilation, and known neurological abnormalities that could affect response to pain. Anticipation of transfer to another institution. Prior ROP screening
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31486844
Citation
Szigiato AA, Speckert M, Zielonka J, Hollamby K, Altomare F, Ng E, Nisenbaum R, Sgro M. Effect of Eye Masks on Neonatal Stress Following Dilated Retinal Examination: The MASK-ROP Randomized Clinical Trial. JAMA Ophthalmol. 2019 Nov 1;137(11):1265-1272. doi: 10.1001/jamaophthalmol.2019.3379.
Results Reference
derived

Learn more about this trial

The Effect of Eyemasks on Neonatal Stress Following Dilated Retinal Examination

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