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

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ClinicalTrials.gov Identifier: NCT03824782
Recruitment Status : Completed
First Posted : January 31, 2019
Last Update Posted : January 31, 2019
Sponsor:
Collaborator:
St. Michael's Hospital, Toronto
Information provided by (Responsible Party):
Dr. Eugene Ng, Sunnybrook Health Sciences Centre

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.

Condition or disease Intervention/treatment Phase
Retinopathy of Prematurity Pain Premature Infant Retinal Disease Device: Phototherapy Mask Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A dual-centre, prospective parallel group trial with balanced randomization (1:1) will be conducted.
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Eyemasks on Neonatal Stress Following Dilated Retinal Examination, a Randomized Clinical Trial
Actual Study Start Date : April 1, 2016
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard of Care
Infants in the control arm received standard examinations to screen for retinopathy of prematurity.
Experimental: Standard of Care + Phototherapy Mask
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.
Device: Phototherapy Mask
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 Measures :
  1. Number of all stressful events [ Time Frame: 12 hours after examination ]

    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 :
  1. Number of desaturations [ Time Frame: 12 hours ]

    Count of events 12 hours after examination, adjusted for baseline rate of events 12 hours prior to examination.

    Desaturation = Pulse oxymetry <88%.


  2. Number of bradycardic events [ Time Frame: 12 hours ]

    Count of events 12 hours after examination, adjusted for baseline rate of events 12 hours prior to examination.

    Bradycardia = HR < 100bpm


  3. Number of apneic events [ Time Frame: 12 hours ]
    Count of events 12 hours after examination, adjusted for baseline rate of events 12 hours prior to examination.

  4. Heart Rate [ Time Frame: 4 hours ]
    Heart Rate (bpm) recorded every hour after the ROP exam

  5. Respiratory Rate [ Time Frame: 4 hours ]
    Respiratory Rate (RPM) recorded every hour after the ROP exam

  6. Oxygen saturation [ Time Frame: 4 hours ]
    Oxygen saturation (Oximetry %) recorded every hour after the ROP exam



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03824782


Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
St. Michael's Hospital, Toronto
  Study Documents (Full-Text)

Documents provided by Dr. Eugene Ng, Sunnybrook Health Sciences Centre:

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Responsible Party: Dr. Eugene Ng, Chief, Newborn & Developmental Paediatrics, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03824782     History of Changes
Other Study ID Numbers: 307-2016
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Eugene Ng, Sunnybrook Health Sciences Centre:
Retinopathy of Prematurity
ROP
Screening
Stress
Pain
Photophobia
Neonate
Light Sensitivity
Desaturation
Bradycardia
Apnea

Additional relevant MeSH terms:
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Retinal Diseases
Premature Birth
Retinopathy of Prematurity
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs