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Pain Relief at Screening for Retinopathy of Prematurity - The PROPER study
EU CTIS ID: 2023-507975-23-01
What this study is testing
To determine whether intranasal dexmedetomidine (DEX) 2 µg/kg, as an adjunct to standard care, provides lower procedural pain scores during ROP screening compared to placebo in preterm infants born at GA <30 weeks.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Preterm infants with GA <30 weeks who receive routine ROP screening and signed parental informed consent
You likely can't join if
- 1. Received pharmacological sedation/analgesia (except sucrose) within 24 hours before the eye examination 2. Severe intraventricular hemorrhage (grade 3-4) 3. Cerebral malformations 4. Congenital heart disease 5. Arrhythmia 6. Mechanical ventilation or vasopressor at the time of the examination 7. Nasal anatomical abnormalities that may interfere with intranasal drug administration or absorption 8. Hypersensitivity to dexmedetomidine or to any of its excipients 9. Uncontrolled hypotension 10. Acute cerebrovascular conditions other than those already listed 11. Clinically significant pre-existing bradycardia not attributable to apnea or other reversible causes 12. Severe hepatic impairment
The study team makes the final eligibility decision.
Where it's taking place
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.