A Phase 1/2 interventional study of Fentanyl Citrate (Intranasal) and Normal Saline (Placebo, Intranasal) in Neonatal Pain, Retinopathy of Prematurity (ROP) and Pain Management, sponsored by Marsha Campbell-Yeo. Not yet recruiting at 1 site in Canada. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Marsha Campbell-Yeo · Phase 1/2, Interventional, and Treatment
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.
Retinopathy of prematurity (ROP) screening is an essential part of the care of preterm infants. Despite the routine use of standard comfort measures, the examination remains associated with moderate-to-high pain intensity scores in many infants. Repeated exposure to untreated or undertreated procedural pain in preterm infants has been associated with adverse short- and long-term effects, highlighting the need for additional evidence-based pain management strategies.
Intranasal fentanyl has several characteristics that make it a promising option for procedural pain management. It has a rapid onset of action, is easy to administer, avoids the need for intravenous access, and has been shown to be effective and well tolerated for procedural pain in older infants and children. Emerging neonatal evidence, including randomized controlled trials, suggests that intranasal fentanyl may reduce pain during ROP screening, but additional high-quality evidence is needed to establish its effectiveness and safety in preterm infants.
This randomized, double-blind, placebo-controlled clinical trial will evaluate whether intranasal fentanyl, when used in addition to standard comfort measures, reduces pain during routine ROP screening while maintaining an acceptable safety profile. The study is designed to provide high-quality evidence to help determine whether intranasal fentanyl should be considered as an additional option for pain management during this necessary neonatal procedure.
The findings from this study may help improve pain management for preterm infants undergoing ROP screening and contribute to future evidence-based clinical practice guidelines for neonatal procedural pain management.
169 studies on the registry are indexed under Retinopathy of Prematurity; 27 are open to participants now.
This study's planned enrollment of 58 is below the median of 82 across 102 interventional studies indexed under Retinopathy of Prematurity.
Browse Retinopathy of Prematurity studies →This is the only study on the registry with Marsha Campbell-Yeo as lead sponsor.
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Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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.
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.
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.
Time frame: First 30 seconds after speculum insertion during ROP screening
Proportion of infants with low to mild pain
The proportion of infants experiencing low or mild pain will be determined using PIPP-R score thresholds (≤6), assessed by blinded coders from synchronized video recordings during and following the ROP examination.
Time frame: During procedure and at 1- and 5-minutes post-procedure
Ongoing pain response during ROP screening
Pain response will be assessed using PIPP-R scores measured at 30-second intervals from speculum insertion until completion of the ROP examination, coded from synchronized video by blinded assessors.
Time frame: Every 30 seconds during the procedure
Pain recovery following ROP screening
Pain recovery will be evaluated using PIPP-R scores measured at 1 and 5 minutes following completion of the ROP examination to assess resolution of pain.
Time frame: 1-minute and 5-minutes post-procedure
Cry duration
Total cry duration (in seconds) will be measured from synchronized video recordings during the ROP examination and recovery period by trained, blinded assessors.
Time frame: From speculum insertion through 5 minutes post-procedure
Salivary cortisol response
Salivary cortisol will be measured as a biologic marker of stress response, collected at baseline (20 minutes pre-procedure) and 20 minutes post-procedure to assess change from baseline.
Time frame: 20 minutes pre-procedure and 20 minutes post-procedure
Adverse events
Safety will be evaluated by monitoring predefined adverse events including apnea, bradycardia, hypotension, chest wall rigidity, oxygen desaturation, and requirement for airway support following intranasal administration.
Time frame: During the procedure and up to 4 hours post-intervention
Duration of ROP examination
Total duration of the ROP examination will be measured in seconds from speculum insertion to removal using timestamped video recordings.
Time frame: During the procedure
Physiological responses
Physiological parameters including heart rate, respiratory rate, oxygen saturation, and blood pressure will be recorded as indicators of physiological response to the procedure, using synchronized bedside monitoring data.
Time frame: Baseline, during the procedure, and at 1- and 5-minutes post-procedure
Plan to share: Undecided — The plan to share individual participant data (IPD) is currently undecided. IPD sharing may be considered in the future depending on institutional policies, ethics approval, and participant consent. If data sharing is pursued, it will involve de-identified data underlying published results, and appropriate data use agreements and secure access mechanisms will be established. No final decision has been made at this stage.
Start is estimated for Sep 2026; primary completion for Mar 2028, 17 months later.
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Studies of the drug tested here: Fentanyl