Clinical Trial

Use of Intranasal Midazolam to Reduce Stress and Procedural Pain in Premature Infants During Routine ROP Examination.

Not Yet Recruiting Phase 1
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Record status
This record was last updated March 21, 2025 (before its estimated June 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
The goal of this study is to learn about the safety and effectiveness of intranasal midazolam in newborns and infants born prematurely, undergoing Retinopathy of Prematurity (ROP) screening. The main question it aims to answer is: • Does use of intranasal midazolam is a safe, quick, non-invasive medication, that reduces the pain, stress, discomfort, and other complications in patients undergoing ROP screening? Researchers will compare the intervention group with a comparison group of the patients who will receive routine comfort care.
Trial Details
NCT Number NCT06889376
Lead Sponsor Polish Mother Memorial Hospital Research Institute
Conditions Drug Safety
Enrollment 40 participants
Start Date 2025-03-24
Primary Completion 2025-06-01 (estimated)
Study Completion 2025-07-06 (estimated)
Updated on ClinicalTrials.gov 2025-03-21