Use of Intranasal Midazolam to Reduce Stress and Procedural Pain in Premature Infants During Rout… (NCT06889376) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Use of Intranasal Midazolam to Reduce Stress and Procedural Pain in Premature Infants During Routine ROP Examination.
Poland40 participantsStarted 2025-03-24
Plain-language 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.
Who can participate
Age range
30 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Newborns qualified for ophthalmologic screening examination to detect retinopathy of prematurity (ROP):
a. Newborns/infants born before the 32 weeks of gestation and/or with a birth weight \<1500 g.
* Obtaining informed consent from a parent/legal guardian.
Exclusion Criteria:
* Newborns/infants not qualified for screening ophthalmologic examination (ROP).
* Newborns/infants clinically unstable, with respiratory disorders/cardiovascular instability before the ophthalmologic examination.
* Newborns/infants with congenital developmental defects.
* Newborns/infants receiving analgesic/sedative medications for other reasons.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain assessment pre and post intranasal midazolam administration
Timeframe: PIPP Score Assessment Time Points: 5 minutes before drug administration, during drug administration, 10, 30 minutes 1 hour and 2 hours post-procedure
Trial details
NCT IDNCT06889376
SponsorPolish Mother Memorial Hospital Research Institute