Pain Relief at Screening for Retinopathy of Prematurity - The PROPER study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

St. Olavs Hospital HF

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Decision date (initial)

2026-06-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

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.

Secondary objectives 1

1. Physiological stability (heart rate, respiratory rate, oxygen saturation, supplemental oxygen requirements, and cardiorespiratory adverse events) during and for 6 hours after IMP administration; Analgesic effect at the time of speculum removal as a secondary measure of pain trajectory; Respiratory support requirements as a measure of respiratory safety; Duration of the first cry episode after ROP screening; Total sleep duration during the first 6 hours after ROP screening; Gastrointestinal tolerability measured by number of vomiting episodes; Cerebral blood flow velocities measured by NeoDoppler before, during, and after ROP screening; EXPLORATORY: Longitudinal blood flow patterns across the NeoDoppler monitoring period; Association between cerebral Doppler velocities and pain scores (PIPP-R); Ophthalmologist's assessment of examination conditions and infant behaviour (VAS).

Conditions and MedDRA coding

Retinopathy of prematurity

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Preterm infants with GA <30 weeks who receive routine ROP screening and signed parental informed consent

Exclusion criteria 1

1. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Pain score assessed with the Premature Infant Pain Profile-Revised (PIPP-R) during the 30 seconds following speculum insertion (Eye exam I and II)

Secondary endpoints 1

1. 1.HR, RR, oxygen saturation, and supplemental oxygen requirement 2. Number of cardiorespiratory events. 3. PIPP-R score following speculum removal. 4. Change in respiratory support mode. 5. Duration of first cry episode. 6. Total sleep duration. 7. Number of vomiting episodes. 8. Cerebral blood flow velocities. Exploratory endp: 1.NeoDoppler blood flow patterns. 2. Cerebral Doppler velocities and pain score. 3. Ophthalmologist VAS score

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

St. Olavs Hospital HF

Sponsor organisation

St. Olavs Hospital HF

Address

Prinsesse Kristinas G. 3

City

Trondheim

Postcode

7030

Country

Norway

Scientific contact point

Organisation

St. Olavs Hospital HF

Contact name

Laila Kristoffersen

Public contact point

Organisation

St. Olavs Hospital HF

Contact name

Laila Kristoffersen

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications