The Effect of Eyemasks on Neonatal Stress Following Dilated Retinal Examination

NCT03824782 | Completed

• 1 other identifier: 307-2016
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinopathy of Prematurity; Pain; Premature Infant; Retinal Disease

Keywords

Retinopathy of Prematurity; ROP; Screening; Stress; Pain; Photophobia; Neonate; Light Sensitivity; Desaturation; Bradycardia; Apnea

Outcome Measures

Primary Outcomes (1)

• 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

  12 hours after examination

Secondary Outcomes (6)

• Number of desaturations

  12 hours

• Number of bradycardic events

  12 hours

• Number of apneic events

  12 hours

• Heart Rate

  4 hours

• Respiratory Rate

  4 hours

Study Arms (2)

Standard of Care

NO INTERVENTION

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

Standard of Care + Phototherapy Mask

EXPERIMENTAL

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

Interventions

Phototherapy Mask DEVICE

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.

Standard of Care + Phototherapy Mask

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Unity Health Toronto: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

Related Publications (1)

• 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.

  PMID: 31486844 DERIVED

MeSH Terms

Conditions

Retinopathy of Prematurity; Pain; Premature Birth; Retinal Diseases; Photophobia; Bradycardia; Apnea

Condition Hierarchy (Ancestors)

Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vision Disorders; Sensation Disorders; Nervous System Diseases; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Newborn & Developmental Paediatrics

Model Details: A dual-centre, prospective parallel group trial with balanced randomization (1:1) will be conducted.

Study Record Dates

• First Submitted: January 21, 2019
• First Posted: January 31, 2019
• Study Start: April 1, 2016
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: January 31, 2019

Record last verified: 2019-01

Locations

CA (1)