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NCT07112430
Fentanyl Intranasal for Retinopathy of Prematurity Screening in Preterm Infants
Conditions: Neonatal Pain, Retinopathy of Prematurity (ROP), Pain Management, Infant, Premature, Fentanyl, Infant, Newborn, Neonatal Intensive Care Units, Analgesia, Intranasal Drug Administration
Sex: All
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 58
Sponsor: Marsha Campbell-Yeo
Location: IWK Health Halifax Nova Scotia
Summary
The goal of this clinical trial is to learn whether intranasal fentanyl (a pain medicine given as a nasal spray) can reduce pain and is safe to use during routine eye examinations for retinopathy of prematurity (ROP) in preterm infants. ROP is an eye condition that can affect babies born too early and requires regular eye examinations. The main questions this study aims to answer are: Does intranasal fentanyl lower pain during ROP screening? Is intranasal fentanyl safe for preterm infants? Researchers will compare intranasal fentanyl with a placebo (a saltwater spray that contains no medicine) to determine whether the medicine lowers pain during ROP screening.
Participants will receive either intranasal fentanyl or placebo before their routine ROP eye examination, in addition to the standard comfort measures normally used during the procedure. Researchers will measure participants' pain and monitor their heart rate, oxygen levels, and any side effects during and after the examination.
Eligibility Criteria
Inclusion Criteria
* Preterm infants born ≤31 weeks gestational age and/or with birth weight \
Source: ClinicalTrials.gov (NCT07112430). StuddyBuddy aggregates publicly available trial information.