Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE January 21, 2019
First Posted Date  ICMJE January 31, 2019
Last Update Posted Date January 31, 2019
Actual Study Start Date  ICMJE April 1, 2016
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2019)
  • 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%.
  • 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
  • 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.
  • Heart Rate [ Time Frame: 4 hours ]
    Heart Rate (bpm) recorded every hour after the ROP exam
  • Respiratory Rate [ Time Frame: 4 hours ]
    Respiratory Rate (RPM) recorded every hour after the ROP exam
  • Oxygen saturation [ Time Frame: 4 hours ]
    Oxygen saturation (Oximetry %) recorded every hour after the ROP exam
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Eyemasks on Neonatal Stress Following Dilated Retinal Examination
Official Title  ICMJE The Effect of Eyemasks on Neonatal Stress Following Dilated Retinal Examination, a Randomized Clinical Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Retinopathy of Prematurity
  • Pain
  • Premature Infant
  • Retinal Disease
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Phototherapy Mask
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 29, 2019)
51
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 30, 2017
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03824782
Other Study ID Numbers  ICMJE 307-2016
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Dr. Eugene Ng, Sunnybrook Health Sciences Centre
Study Sponsor  ICMJE Sunnybrook Health Sciences Centre
Collaborators  ICMJE St. Michael's Hospital, Toronto
Investigators  ICMJE Not Provided
PRS Account Sunnybrook Health Sciences Centre
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP