NCT07112430 - Fentanyl Intranasal for Retinopathy of Prematurity Screening in Preterm Infants | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

October 1, 2026

Study Completion Date

May 1, 2027

Conditions

Neonatal PainRetinopathy of Prematurity (ROP)Pain ManagementInfant, PrematureFentanylInfant, NewbornNeonatal Intensive Care UnitsAnalgesiaIntranasal Drug Administration

Interventions

DRUG

Fentanyl Citrate (Intranasal)

Fentanyl citrate will be administered intranasally at a dose of 2 mcg/kg via a mucosal atomization device, 5 minutes prior to ROP screening. Used in conjunction with standard non-pharmacologic comfort strategies.

DRUG

Normal Saline (Placebo, Intranasal)

An equivalent volume of intranasal normal saline will be administered using a mucosal atomization device, 5 minutes prior to ROP screening.