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.
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