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

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507975-23-01
Enrollment
33
Registered
2026-06-22
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinopathy of prematurity

Brief summary

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

Detailed description

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

Interventions

DRUGOxibuprokain Minims 4 mg/ml øyedråper
DRUGoppløsning.
DRUGMetaoxedrin Minims 100 mg/ml øyedråper
DRUGoppløsning
DRUGNaCl 0
DRUGInjektionslösung
DRUGCyclopentolat Minims 10 mg/ml øyedråper

Sponsors

St. Olavs Hospital HF
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Outcome results

None listed

Source: EU CTIS · Data processed: Jun 23, 2026