New treatment option for Retinopathy of Prematurity
Official title Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity
ClinicalTrials.gov ID: NCT06067958
What this study is testing
What is Dexmedetomidine?
Dexmedetomidine is an investigational medicine, being studied as a potential treatment for retinopathy of prematurity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 and older
You may be able to join if
- Gestational age \< 31 weeks post-menstrual age, or birth weight \< 1500 grams
- Informed consent signed by one of the parents
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Be’er Ya‘aqov, Center, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 4 weeks and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Be’er Ya‘aqov, Center, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.