Clin2
NCT07112430Possibly a fitNot yet recruiting

Nasal fentanyl for pain relief during ROP eye exams in premature babies

Neonatal PainRetinopathy of Prematurity (ROP)Pain ManagementInfant, PrematureFentanylInfant, NewbornNeonatal Intensive Care UnitsAnalgesia

Treatments studied

Part of Brain & nervous system, Eyes & vision, Genetic & congenital, Pain, Women’s health & pregnancy clinical trials.

This study tests a new way to give a nasal spray of fentanyl (a strong painkiller) to premature babies before their routine eye exams for ROP. It aims to see if this medicine reduces pain and discomfort during the exam better than current standard care.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 1/Phase 2
Enrollment
58 people
Ages
Any age
Study type
Interventional

Who can take part

  • Baby born at or before 31 weeks of pregnancy, or weighed less than 1250 grams at birth
  • Baby is scheduled for routine eye exams for retinopathy of prematurity (ROP) as part of their NICU care
  • Baby is stable (no need for emergency breathing help in the last 24 hours, and heart rate and breathing are steady)
  • Parent or legal guardian can give written permission for the baby to join
  • Baby does not have any birth defects or conditions affecting the nose that would make the nasal spray hard to give
  • Baby has not received strong pain or sedation medications in the last 24 hours, and is not allergic to fentanyl

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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