Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity

Recruiting Phase 3 Interventional Study
Retinopathy of Prematurity Dexmedetomidine
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
4 Weeks and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Assaf-Harofeh Medical Center · Government
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About This Trial
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 examinations are known to cause significant pain and stress, the current standard of care (sucrose and local anesthesia) is not adequate in terms of alleviation of pain. Purpose: The goal of this clinical trial…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Gestational age \< 31 weeks post-menstrual age, or birth weight \< 1500 grams * Informed consent signed by one of the parents Exclusion Criteria: * Invasive ventilation at the time of the eye assessment * Multiple congenital anomalies * Chromosomal / genetic anomalies * Infa…
Contacts

Sagee Nissimov, MD

97289779080

sageen@shamir.gov.il

CONTACT

Iris Morag, MD

97289778286

IRISMO@shamir.gov.il

CONTACT