Skip to main content
OpenTrials
Completed

NCT Number: NCT07016984

Comfort Level in Premature Infants Undergoing Retinopathy of Prematurity Screening

Retinopathy of prematurity (ROP) screening is a routine yet painful procedure for premature infants, often necessitating pharmacological mydriasis. The associated light exposure due to dilated pupils can increase stress and reduce infant comfort. This study aimed to investigate the effect of using a phototherapy eye mask during mydriasis on the comfort levels of premature infants.

Completed

Looking for future studies?

Notify Me

Key information

About this study

Retinopathy of prematurity is a pathological condition affecting the developing retinal blood vessels in low birth weight premature infants and is one of the leading causes of childhood blindness. In recent years, advancements in neonatal intensive care in developing countries such as China, India, and Turkey have increased the survival rates of premature infants, consequently raising the number of infants requiring ROP screening examinations. Health Organization (WHO) recommends conducting the initial ROP examination before the infant is discharged from the hospital. However, ROP screening is a painful and stressful procedure that includes the administration of mydriatic agents, the insertion of a speculum to open the palpebral fissure, and scleral depression to visualize the retinal periphery. These interventions often result in discomfort and distress for the infant. Globally, most newborns admitted to neonatal intensive care units (NICUs) undergo repeated painful procedures. It is well-established that premature infants can perceive pain, and exposure to pain during the early stages of life may lead to long-term neurological consequences. In very preterm infants, early exposure to procedural pain has been associated with impaired cognitive development and reductions in frontal and parietal lobe volumes, brain size, white matter, and subcortical gray matter. Considering the frequency of painful interventions during hospitalization, gaining deeper insight into stress-inducing factors and exploring methods to enhance infant comfort is of great importance. Various non-pharmacological interventions-such as pacifiers, music, and oral sucrose-have been studied for their effectiveness in reducing pain and stress during ROP examinations. However, research evaluating the effect of minimizing light exposure during pupil dilation (mydriasis) is limited. Mydriatic eye drops, used to dilate the pupils for examination, are known to cause light sensitivity and photophobia. It is hypothesized that the increased light sensitivity resulting from pupil dilation before the examination contributes to infant discomfort and stress. Therefore, this study aims to investigate the effect of reducing light exposure-by applying eye patches during the mydriasis process-on the comfort levels of premature infants undergoing ROP screening.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gestational age ≤34 weeks
  • Birth weight ≤1700 grams
  • Parental consent to participate in the study

Exclusion criteria

  • Required mechanical ventilation during the study period
  • Had genetic disorders, heart disease, neurological or metabolic conditions, pulmonary anomalies, or ocular malformations
  • Had any conditions affecting the stress response
  • Were administered sedatives, muscle relaxants, corticosteroids, or analgesics
  • Had major congenital anomalies

Treatment and study plan

standard phototherapy eye patches

Other

Following the mydriasis procedure performed prior to ROP examination, the eyes were covered with these patches.

Primary outcomes

  1. post-test total and subdimension scores from the Premature Infant Comfort Scale (PICS), along with the statistical comparisons between the two groups

    Time frame: 8 hours

    Statistically significant differences were observed in the total scores and all subdimensions of the PICS-alertness, calmness/agitation, crying (in non-ventilated infants), physical movement, muscle tone, facial movements, and average heart rate

Sponsors and collaborators

Lead sponsor

Istanbul Nisantasi University

Other

Registry information

Official study title

Effect of Light Intensity Reduction During Mydriasis on the Comfort Level in Premature Infants Undergoing Retinopathy of Prematurity Screening

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 12, 2025
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.