Fentanyl Intranasal for Retinopathy of Prematurity Screening in Preterm Infants

NCT07112430 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: IWK_INF_PainTrial2025
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neonatal Pain; Retinopathy of Prematurity (ROP); Pain Management; Infant, Premature; Fentanyl; Infant, Newborn; Neonatal Intensive Care Units; Analgesia; Intranasal Drug Administration

Keywords

intranasal fentanyl; fentanyl; neonatal analgesia; procedural pain; ROP screening; Retinopathy of Prematurity; Preterm infants; Premature infants; infant pain; Non-invasive analgesia; Opioid analgesia; Intranasal drug delivery; Neonatal intensive care; NICU; Pain management in neonates; Infant procedural sedation

Outcome Measures

Primary Outcomes (1)

• Pain intensity during ROP screening

  Pain intensity will be measured using the Premature Infant Pain Profile-Revised (PIPP-R). The primary endpoint is the PIPP-R score during the first 30 seconds following speculum insertion during the ROP examination.

  First 30 seconds after speculum insertion during ROP screening

Secondary Outcomes (8)

• Proportion of infants with low to mild pain

  During procedure and at 1- and 5-minutes post-procedure

• Ongoing pain response during ROP screening

  Every 30 seconds during the procedure

• Pain recovery following ROP screening

  1-minute and 5-minutes post-procedure

• Cry duration

  From speculum insertion through 5 minutes post-procedure

• Salivary cortisol response

  20 minutes pre-procedure and 20 minutes post-procedure

Study Arms (2)

Intranasal Fentanyl Group

EXPERIMENTAL

Participants in this group will receive intranasal fentanyl at a dose of 2 mcg/kg administered 10 minutes prior to initiation of retinopathy of prematurity (ROP) screening. The study drug will be delivered via a mucosal atomization device into one nostril. All participants will also receive standard comfort measures as part of routine NICU care, including oral sucrose, non-nutritive sucking, swaddling, and topical anesthetic eye drops.

Drug: Fentanyl Citrate (Intranasal)

Placebo Group

PLACEBO COMPARATOR

Participants in this group will receive an equivalent volume of intranasal 0.9% normal saline placebo administered 10 minutes prior to initiation of retinopathy of prematurity (ROP) screening using a mucosal atomization device. All participants will also receive standard comfort measures as part of routine NICU care, including oral sucrose, non-nutritive sucking, swaddling, and topical anesthetic eye drops.

Drug: Normal Saline (Placebo, Intranasal)

Interventions

Fentanyl Citrate (Intranasal) DRUG

Fentanyl citrate will be administered intranasally at a dose of 2 mcg/kg via a mucosal atomization device 10 minutes prior to retinopathy of prematurity (ROP) screening. The intervention will be delivered into one nostril. All participants will also receive standard comfort measures as part of routine NICU care, including oral sucrose, non-nutritive sucking, swaddling, and topical anesthetic eye drops.

Intranasal Fentanyl Group

Normal Saline (Placebo, Intranasal) DRUG

An equivalent volume of intranasal 0.9% normal saline placebo will be administered via a mucosal atomization device 10 minutes prior to retinopathy of prematurity (ROP) screening. All participants will also receive standard comfort measures as part of routine NICU care, including oral sucrose, non-nutritive sucking, swaddling, and topical anesthetic eye drops.

Placebo Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Preterm infants born ≤31 weeks gestational age and/or with birth weight \<1250 g
• Scheduled to undergo routine retinopathy of prematurity (ROP) screening as part of standard NICU care
• Clinically stable at the time of screening, defined as not requiring acute resuscitative support (no bag-mask ventilation, intubation, or chest compressions within the preceding 24 hours) and maintaining stable cardiorespiratory parameters on baseline respiratory support
• Written informed consent obtained from a parent or legally authorized representative

You may not qualify if:

• Congenital anomalies or conditions affecting the nasal passages that would interfere with intranasal drug administration
• Receipt of systemic opioids, benzodiazepines, barbiturates, or other sedative/analgesic medications within 24 hours prior to the ROP examination
• Known hypersensitivity or prior adverse reaction to fentanyl

Sponsors & Collaborators

• IWK Health Centre: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Marsha Campbell-Yeo: lead
• Dalhousie University: collaborator

Study Sites (1)

IWK Health

Halifax, Nova Scotia, Canada

Location

MeSH Terms

Conditions

Retinopathy of Prematurity; Agnosia; Premature Birth; Pain, Procedural

Interventions

Fentanyl; Saline Solution

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pain

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Helen McCord, BScN, MN, PhD Candidate, NNP

CONTACT

19024971412; mccordhelen@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a quadruple-masked (participant/family, care provider, investigator, and outcome assessor) randomized controlled trial. Blinding is maintained through pharmacy-controlled randomization and preparation of identical syringes containing either intranasal fentanyl or intranasal 0.9% normal saline placebo. Study drug and placebo are matched for volume, appearance, labeling, and administration method using a mucosal atomization device. Clinical staff administering the intervention, investigators, outcome assessors scoring PIPP-R from video recordings, and families remain unaware of treatment allocation throughout the trial. Allocation concealment is ensured by the institutional pharmacy, which maintains the randomization sequence and dispenses study medication according to assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinician Scientist, Neonatal Nurse Practitioner, Professor

Model Details: This is a randomized, double-blind, placebo-controlled, parallel-group trial. Eligible preterm infants born ≤31 weeks gestational age and/or with birth weight \<1250 g who are undergoing routine retinopathy of prematurity (ROP) screening will be randomly assigned in a 1:1 ratio to receive either intranasal fentanyl or intranasal 0.9% normal saline placebo administered 10 minutes prior to the procedure. Participants will receive a single study intervention and will remain in their assigned treatment group throughout the study. The primary aim is to evaluate the analgesic efficacy and safety of intranasal fentanyl compared with placebo during ROP screening.

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 8, 2025
• Study Start (Estimated): September 9, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 30, 2026

Record last verified: 2025-06

Locations

CA (1)