The Effect of Eyemasks on Neonatal Stress Following Dilated Retinal Examination (MASK-ROP)
Retinopathy of Prematurity, Pain, Premature Infant
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
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
No Intervention
Experimental
Standard of Care
Standard of Care + Phototherapy Mask
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.