NCT06889376

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

The Use of Intranasal Sedation With Midazolam to Reduce Stress, Discomfort and Procedural Pain in Preterm Newborns and Infants During Routine ROP Screening

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Polish Mother Memorial Hospital Research Institute · Academic / Other
• Sex: All
• Age: 30 Weeks
• Healthy volunteers: Not accepted

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.

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™ intranasal atomization device in preterm newborns and infants. Participants: Preterm newborns and infants eligible for routine ROP screening. Recruitment: Parental/legal guardian consent required before random assignment to either the study or control group. Study Groups and Randomization: Random Assignment: Block randomization will be used. • Sample Size: 40 newborns/infants (20 in control, 20 in study group). Study intervention and monitoring: • Study Group (midazolam group) 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 minutes before screening. * Swaddling and placement under the radiant warmer. Monitoring: * Vital signs: heart rate, respiratory rate, blood pressure, oxygen saturation recorded 10 minutes before screening until 2 hours post-examination. * Pain assessment (PIPP scale) conducted before, during, and 10, 30 minutes 1 hour and 2 hours post-procedure. * Modified N-PASS scale to assess the level of sedation conducted before, during, 10, 30 minutes 1 hour and 2 hours post-procedure. Control Group (non-midazolam group) * No midazolam administered. * Comfort measures: 1 ml of 20% glucose solution orally with a pacifier 5 minutes before screening. Swaddling and placement under the radiant warmer. Monitoring: * Vital signs: heart rate, respiratory rate, blood pressure, oxygen saturation recorded 10 minutes before screening until 2 hours post-examination. * Pain assessment (PIPP scale) conducted before, during, and 10, 30 minutes 1 hour and 2 hours post-procedure. In both groups, observations for: * 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) * Infections \& Sepsis (Confirmed or suspected based on clinical signs) Study Outcome Assessment: Change in pain and stress symptoms during ROP screening, measured by the Premature Infant Pain Profile (PIPP). Clinical safety of intranasal midazolam using a nasal atomizer (DART™ intranasal atomization device) in newborns/infants. Assessment of sedation post intranasal midazolam administration.

Conditions

• Drug Safety

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2025-03-24
• Primary completion: 2025-06-01
• Completion: 2025-07-06
• First posted: 2025-03-21
• Last updated: 2025-03-21

Locations

1 site across 1 country: Poland