Clinical Research Directory
Browse clinical research sites, groups, and studies.
Use of Intranasal Midazolam to Reduce Stress and Procedural Pain in Premature Infants During Routine ROP Examination.
Sponsor: Polish Mother Memorial Hospital Research Institute
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.
Official title: The Use of Intranasal Sedation With Midazolam to Reduce Stress, Discomfort and Procedural Pain in Preterm Newborns and Infants During Routine ROP Screening
Key Details
Gender
All
Age Range
Any - 30 Weeks
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-03-24
Completion Date
2025-07-06
Last Updated
2025-03-21
Healthy Volunteers
No
Conditions
Interventions
Intranasal midazolam administration via the DART™ intranasal atomization device along with routine comfort care.
Intervention: Intranasal midazolam (0.2 mg/kg) administered 10 minutes before ROP screening via the DART™ intranasal atomization device. Comfort Measures: * 1 ml of 20% glucose solution orally with a pacifier, 5 min before screening. * Swaddling and placement under the radiant warmer. Monitoring: * Vital Signs (heart rate, respiratory rate, blood pressure, oxygen saturation monitoring before drug administration until 2 hours after). * Pain assessment (PIPP scale) conducted before, during, and 10 and 30 min post-procedure. * Modified N-PASS to assess the level of sedation conducted before, during, 10, 30 minutes 1 hour and 2 hours post-procedure Observations for signs of: * Respiratory Distress (apnoea, desaturation, increased work of breathing) * Cardiovascular Instability (Bradycardia, tachycardia, hypotension) * Neurological Symptoms (Lethargy, seizures, abnormal tone) * Gastrointestinal Issues (Feeding intolerance, NEC-like symptoms)
Locations (1)
Polish Mother's Health Center Institute Rzgowska 281/289, 93-338 Lodz
Lodz, Poland