Status:
RECRUITING
Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity
Lead Sponsor:
Assaf-Harofeh Medical Center
Conditions:
Retinopathy of Prematurity
Dexmedetomidine
Eligibility:
All Genders
4+ years
Phase:
PHASE3
Brief Summary
Background: Preterm infants undergo serial eye examinations during their hospital stay to monitor for the development of a specific disease termed "retinopathy of prematurity". While those examination...
Eligibility Criteria
Inclusion
- Gestational age \< 31 weeks post-menstrual age, or birth weight \< 1500 grams
- Informed consent signed by one of the parents
Exclusion
- Invasive ventilation at the time of the eye assessment
- Multiple congenital anomalies
- Chromosomal / genetic anomalies
- Infant received a sedative drug in last 5 days
- Eye examination for reasons other than retinopathy of prematurity screening
- Attending physician deemed the patient not stable enough
Key Trial Info
Start Date :
December 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06067958
Start Date
December 11 2023
End Date
December 1 2025
Last Update
December 6 2024
Active Locations (1)
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1
Assaf-Harofeh Medical Center
Be’er Ya‘aqov, Center, Israel, 7033001