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NCT02152046 · ClinicalTrials.gov registry record
ROP Screening: Comparison of Pain Using Two Eyelid Retractors
A clinical trial, sponsored by Wake Forest University Health Sciences.
- Terminated
- Registry status
- 44
- Enrollment target
NCT02152046: Clinical Trial study, sponsored by Wake Forest University Health Sciences.
NCT02152046 is a clinical trial that was terminated before completion, run by Wake Forest University Health Sciences. The registered enrollment target is 44 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02152046 was terminated before completion, sponsored by Wake Forest University Health Sciences.
- TERMINATED
- Registry status
- 44 participants
- Enrollment target
Study Summary
Retinopathy of prematurity (ROP) is a major cause of blindness in the world. Initial ocular examinations of infants at risk for ROP are generally conducted between 4-6 weeks postnatally. These exams are vital to protect preterm infants from blindness, but these exams have been shown to cause pain in this population. Currently two speculums are utilized; the spring loaded Alfonso and the screw loaded Cook eyelid speculum. There is no schedule for who receives which speculum during their exam. The objective of this study is to evaluate the pain response in the neonatal population, 32 weeks or less, and less than or equal to 1500 grams, undergoing a retractor eye exam for retinopathy of prematurity (ROP) screening. The primary study aim is to compare the N-PASS pain score between neonates who received a ROP eye exam with the spring loaded Alfonso and the screw loaded Cook eye speculums.
Primary Outcome
With each exam, an N-PASS score will be recorded: just prior to the start of the exam; between each eye; at the end of the exam and every minute for five minutes from the completion of the exam.
Interventions
- PROCEDURE ROP exam with spring loaded retractor
- PROCEDURE ROP exam with screw retractor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2014-06-20 |
| Est. Completion | 2024-06-24 |
Why NCT02152046 stopped before completion
NCT02152046 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 44 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which ROP exam with spring loaded retractor is the first listed.
NCT02152046 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02152046 about?
NCT02152046 is a clinical study titled "ROP Screening: Comparison of Pain Using Two Eyelid Retractors". Retinopathy of prematurity (ROP) is a major cause of blindness in the world. Initial ocular examinations of infants at risk for ROP are generally conducted between 4-6 weeks postnatally. These exams are vital to protect preterm infants from blindness, but these exams have been shown to cause pain in...
What is the current status of trial NCT02152046?
This trial is currently terminated. The enrollment target is 44 participants. The study started on 2014-06-20. Estimated completion is 2024-06-24.
What interventions are being tested in trial NCT02152046?
The interventions under investigation include: ROP exam with spring loaded retractor (PROCEDURE), ROP exam with screw retractor (PROCEDURE).
Who is sponsoring clinical trial NCT02152046?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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