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Nasal fentanyl spray could ease painful eye exams for premature babies

NCT ID NCT07112430

Symptom relief Sponsor: Marsha Campbell-Yeo Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This trial tests whether a fentanyl nasal spray can reduce pain during eye exams for retinopathy of prematurity (ROP) in preterm infants. About 58 babies born at or before 31 weeks will receive either fentanyl or a saltwater placebo before their routine exam, along with standard comfort measures like sugar water and swaddling. Researchers will measure pain scores and monitor heart rate, oxygen levels, and side effects to see if the spray is safe and effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
fentanyl citrate (intranasal spray)
What this could lead to
If effective, this could provide a safe, non-invasive way to ease pain during routine eye exams for premature babies.
What could go wrong
This is an early-phase trial with only 58 infants, so results may not apply broadly. Fentanyl carries risks like breathing problems in newborns.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 58 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * 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 Exclusion Criteria * 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

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Conditions

The condition(s) this trial relates to.

agnosia pain agnosia Pain, Procedural Premature Birth retinopathy of prematurity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Analgesia Fentanyl Infant, newborn Infant, premature Intranasal drug administration Neonatal intensive care units Neonatal pain Pain management Retinopathy of prematurity (ROP)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • IWK Health

    Halifax, Nova Scotia, Canada

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