Effect of Multiple Non-pharmacological Methods for Pain Management During Eye Examination for Retinopathy of Prematurity in Preterm Infants

Launched by ISTANBUL MEDENIYET UNIVERSITY · Apr 28, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at different non-drug methods to help manage pain in premature infants during eye exams for a condition called retinopathy of prematurity (ROP). ROP is a serious eye disease that can affect babies born too early. The goal of the study is to see how these pain management techniques affect the babies' pain levels and vital signs, like heart rate and breathing.

To participate in this trial, infants must be born at or before 32 weeks of pregnancy or weigh 1500 grams or less at birth. They should be stable and awake, breathing on their own, and having their first eye exam for ROP. However, babies who have received certain medications or have serious health issues, like severe respiratory problems or infections, will not be eligible. If your baby qualifies and participates, they will receive one of the non-drug pain management methods during their eye exam, and researchers will monitor how well it works. This trial is not yet recruiting participants, but it aims to improve pain management for vulnerable infants in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Postmenstrual gestational age ≤32 weeks and/or birth weight ≤1500 g,
• • Stable, awake, in supine position and breathing spontaneously without oxygen support,
• • Vital signs were within normal limits before the examination,
• • Premature infants undergoing ROP examination for the first time.
• Exclusion Criteria:
• • Preterms who have been administered non-steroidal anti-inflammatory drugs or sedative and antiepileptic drugs such as chloral hydrate, phenobarbital and diazepam within 24 hours before the ROP examination,
• • Preterms with severe respiratory diseases, receiving respiratory support (continuous positive airway pressure or mechanical ventilation),
• • Preterms with critical conditions such as central nervous system infections and sepsis,
• • Preterms with other organic diseases such as severe cardiovascular disease, pulmonary insufficiency,
• • Preterms with congenital malformations.