<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03824782</url>
  </required_header>
  <id_info>
    <org_study_id>307-2016</org_study_id>
    <nct_id>NCT03824782</nct_id>
  </id_info>
  <brief_title>The Effect of Eyemasks on Neonatal Stress Following Dilated Retinal Examination</brief_title>
  <acronym>MASK-ROP</acronym>
  <official_title>The Effect of Eyemasks on Neonatal Stress Following Dilated Retinal Examination, a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sunnybrook Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sunnybrook Health Sciences Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Although screening exams for retinopathy of prematurity (ROP) prevent blindness they are&#xD;
      physiologically stressful for infants. The investigators postulate that photosensitivity&#xD;
      during mydriasis contributes to post-examination stress and that reducing light stimulation&#xD;
      with a phototherapy mask can make infants more comfortable. The objective of this study is to&#xD;
      determine the effect of a phototherapy mask worn during mydriasis on infant stress in the 12&#xD;
      hour period following ROP screening.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Retinopathy of Prematurity (ROP) is a disorder of retinal vascular development of the low&#xD;
      birthweight preterm infant that may lead to blindness if untreated. The long term visual&#xD;
      acuity of infants with ROP detected by screening examination can be improved by peripheral&#xD;
      retinal ablation therapy or injection of anti-VEGF agents.&#xD;
&#xD;
      The screening examination for retinopathy of prematurity involves dilation with mydriatic eye&#xD;
      drops, insertion of a lid speculum to retract the eyelids, and depression of the sclera to&#xD;
      visualize the retina. These exams are routinely performed in Neonatal Intensive Care Units&#xD;
      (NICUs) to facilitate early detection of ROP and guide treatment to prevent retinal&#xD;
      detachment and blindness. However, infants undergoing this examination have shown elevations&#xD;
      in heart rate, blood pressure, and desaturations at the time of the examination, and in the&#xD;
      hours following. The frequency of apneic events experienced by these infants is increased in&#xD;
      the 24-48 hour period after an examination.&#xD;
&#xD;
      Several studies have looked at the pain response to mydriatic drops and speculum insertion as&#xD;
      well as the systemic effects of the mydriatic drops. However, the cause of apneic events in&#xD;
      the later post-examination period is unknown. The investigators postulate that&#xD;
      photosensitivity related to mydriasis is distressing for infants in the period before and&#xD;
      after the ROP exam, potentially contributing to stressful events, including apnea.&#xD;
&#xD;
      The investigators propose to test this hypothesis by conducting a dual-centre, prospective&#xD;
      parallel group trial with balanced randomization (1:1), applying a phototherapy mask&#xD;
      (Biliband, Natus, Pleasanton, California, USA) to cover the eyes of the infant after the&#xD;
      instillation of mydriatic drops, leaving the mask on for 4 hours, the typical duration of&#xD;
      mydriasis following a drop of cyclopentolate. The investigators expect that this intervention&#xD;
      will result in a significant reduction in the number of stressful events following an&#xD;
      examination, and may reduce the amount of distress experienced by infants. Infants requiring&#xD;
      ROP screening will be automatically identified as part of routine hospital protocols.&#xD;
      Participants will be recruited from the NICUs at St. Michael's Hospital and Sunnybrook Health&#xD;
      Sciences Hospital in Toronto, Ontario, Canada.&#xD;
&#xD;
      The investigators predict that infants that have had their eyes shielded from environmental&#xD;
      light while dilated are less likely to experience distressful events in the 12 hour period&#xD;
      following ROP screening. If this study shows decreased rates of distress using this therapy,&#xD;
      it would be a very simple addition to current practice and be of benefit for premature&#xD;
      infants undergoing an uncomfortable exam.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2016</start_date>
  <completion_date type="Actual">June 30, 2017</completion_date>
  <primary_completion_date type="Actual">June 30, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>A dual-centre, prospective parallel group trial with balanced randomization (1:1) will be conducted.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of all stressful events</measure>
    <time_frame>12 hours after examination</time_frame>
    <description>Count of all desaturations, bradycardic events, and apneic events, adjusted for baseline rate of stressful events 12 hours prior to examination.&#xD;
Infants are under continuous vital sign monitoring and these events are flagged using the following parameters:&#xD;
Desaturation = Pulse oxymetry &lt;88% Bradycardia = Heart rate &lt;100bpm Apneic episode = Cessation of respiratory effort &gt;20 seconds, or less if accompanied by bradycardia, cyanosis or pallor</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of desaturations</measure>
    <time_frame>12 hours</time_frame>
    <description>Count of events 12 hours after examination, adjusted for baseline rate of events 12 hours prior to examination.&#xD;
Desaturation = Pulse oxymetry &lt;88%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of bradycardic events</measure>
    <time_frame>12 hours</time_frame>
    <description>Count of events 12 hours after examination, adjusted for baseline rate of events 12 hours prior to examination.&#xD;
Bradycardia = HR &lt; 100bpm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of apneic events</measure>
    <time_frame>12 hours</time_frame>
    <description>Count of events 12 hours after examination, adjusted for baseline rate of events 12 hours prior to examination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart Rate</measure>
    <time_frame>4 hours</time_frame>
    <description>Heart Rate (bpm) recorded every hour after the ROP exam</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory Rate</measure>
    <time_frame>4 hours</time_frame>
    <description>Respiratory Rate (RPM) recorded every hour after the ROP exam</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen saturation</measure>
    <time_frame>4 hours</time_frame>
    <description>Oxygen saturation (Oximetry %) recorded every hour after the ROP exam</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Retinopathy of Prematurity</condition>
  <condition>Pain</condition>
  <condition>Premature Infant</condition>
  <condition>Retinal Disease</condition>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Infants in the control arm received standard examinations to screen for retinopathy of prematurity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care + Phototherapy Mask</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Phototherapy Mask</intervention_name>
    <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.</description>
    <arm_group_label>Standard of Care + Phototherapy Mask</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infant with birthweight of ≤1500 g or less or a gestational age of ≤ 32 weeks with no&#xD;
             prior ROP screening. Examinations will be performed starting at either 4 weeks&#xD;
             chronological age or 31 weeks post menstrual age, whichever is later.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-existing corneal abrasion/ulcers, ocular malformations that prevent dilation, and&#xD;
             known neurological abnormalities that could affect response to pain.&#xD;
&#xD;
          -  Anticipation of transfer to another institution.&#xD;
&#xD;
          -  Prior ROP screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>January 29, 2019</last_update_submitted>
  <last_update_submitted_qc>January 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sunnybrook Health Sciences Centre</investigator_affiliation>
    <investigator_full_name>Dr. Eugene Ng</investigator_full_name>
    <investigator_title>Chief, Newborn &amp; Developmental Paediatrics</investigator_title>
  </responsible_party>
  <keyword>Retinopathy of Prematurity</keyword>
  <keyword>ROP</keyword>
  <keyword>Screening</keyword>
  <keyword>Stress</keyword>
  <keyword>Pain</keyword>
  <keyword>Photophobia</keyword>
  <keyword>Neonate</keyword>
  <keyword>Light Sensitivity</keyword>
  <keyword>Desaturation</keyword>
  <keyword>Bradycardia</keyword>
  <keyword>Apnea</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinal Diseases</mesh_term>
    <mesh_term>Retinopathy of Prematurity</mesh_term>
    <mesh_term>Premature Birth</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 23, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT03824782/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03824782
org study id: 307-2016
nct id: NCT03824782
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A dual-centre, prospective parallel group trial with balanced randomization (1:1) will be conducted.
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Number of all stressful events
time frame: 12 hours after examination
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
measure: Number of desaturations
time frame: 12 hours
description: Count of events 12 hours after examination, adjusted for baseline rate of events 12 hours prior to examination.
Desaturation = Pulse oxymetry <88%.
measure: Number of bradycardic events
time frame: 12 hours
description: Count of events 12 hours after examination, adjusted for baseline rate of events 12 hours prior to examination.
Bradycardia = HR < 100bpm
measure: Number of apneic events
time frame: 12 hours
description: Count of events 12 hours after examination, adjusted for baseline rate of events 12 hours prior to examination.
measure: Heart Rate
time frame: 4 hours
description: Heart Rate (bpm) recorded every hour after the ROP exam
measure: Respiratory Rate
time frame: 4 hours
description: Respiratory Rate (RPM) recorded every hour after the ROP exam
measure: Oxygen saturation
time frame: 4 hours
description: Oxygen saturation (Oximetry %) recorded every hour after the ROP exam
arm group label: Standard of Care
arm group type: No Intervention
description: Infants in the control arm received standard examinations to screen for retinopathy of prematurity.
arm group label: Standard of Care + Phototherapy Mask
arm group type: Experimental
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: Phototherapy Mask
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.
arm group label: Standard of Care + Phototherapy Mask
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Sunnybrook Health Sciences Centre
investigator full name: Dr. Eugene Ng
investigator title: Chief, Newborn & Developmental Paediatrics
mesh term: Retinal Diseases
mesh term: Retinopathy of Prematurity
mesh term: Premature Birth
sharing ipd: Undecided
provided document: 