Status:
NOT_YET_RECRUITING
Use of Intranasal Midazolam to Reduce Stress and Procedural Pain in Premature Infants During Routine ROP Examination.
Lead Sponsor:
Polish Mother Memorial Hospital Research Institute
Conditions:
Drug Safety
Eligibility:
All Genders
Up to 30 years
Phase:
PHASE1
Brief 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...
Detailed Description
The aim of this parallel, prospective, nonblinded randomised control trial is to assess the effectiveness and safety of intranasal midazolam administered before ROP screening using the DART™ intranasa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 6 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06889376
Start Date
March 24 2025
End Date
July 6 2025
Last Update
March 21 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Polish Mother's Health Center Institute Rzgowska 281/289, 93-338 Lodz
Lodz, Poland, 93-338