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

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

March 24, 2025

Primary Completion Date

June 1, 2025

Study Completion Date

July 6, 2025

Conditions
Drug Safety
Interventions
DRUG

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)"

Trial Locations (1)

93-338

Polish Mother's Health Center Institute Rzgowska 281/289, 93-338 Lodz, Lodz

All Listed Sponsors
lead

Polish Mother Memorial Hospital Research Institute

OTHER