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

2023-507975-23-01 · tracked via the Priya Life Science EU tracker

Sponsor

St. Olavs Hospital HF

Sponsor type

Hospital/Clinic/Other health care facility

Therapeutic area

Eye Diseases

Decision date

22/06/2026

Enrollment target

Sites

Norway

Condition studied

Retinopathy of prematurity

Investigational medicinal product(s)

Oxibuprokain Minims 4 mg/ml øyedråperoppløsning.Dexmedetomidine 100 micrograms/ml concentrate for solution for infusionMetaoxedrin Minims 100 mg/ml øyedråperoppløsningNaCl 09 % B. BraunInjektionslösungCyclopentolat Minims 10 mg/ml øyedråperoppløsning

Eligibility

Age group

0-17 years

Sex

Female, Male

Primary endpoint

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

Endpoint detail

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

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2023-507975-23-01 on CTIS ↗ ← All trials in the EU