40
Participants
Start Date
March 24, 2025
Primary Completion Date
June 1, 2025
Study Completion Date
July 6, 2025
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)"
Polish Mother's Health Center Institute Rzgowska 281/289, 93-338 Lodz, Lodz
Polish Mother Memorial Hospital Research Institute
OTHER