Evaluating pain relief methods during eye exams for premature infants
Official title: The Effect of Reverse Kangaroo Care Position and ROP Position on Pain During Retinopathy Examination in Premature Infants
Run by Ege University · NCT06694103 · Data updated 2026-11-12
This study is testing two different ways to hold premature infants during eye exams to see which one helps reduce their pain better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 28 Weeks to 33 Weeks |
| Sex | All |
| Enrollment | 84 (estimated) |
| Sponsor | Ege University Academic / other |
| Locations | 1 site (Izmir, Menemen) |
| Status | Recruiting |
| Started | February 19, 2024 |
| Main results expected | June 30, 2025 |
| Study ends | July 30, 2025 |
| Registry record updated | November 19, 2024 |
| Trial ID | NCT06694103 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are premature infants with a gestational age of less than 34 weeks and a birth weight of 2500 grams or less.
✕Probably not a fit
Patients with conditions that prevent pain assessment or those who have undergone painful procedures shortly before the examination may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of two positioning techniques, reverse kangaroo care and standard ROP position, in reducing pain during retinopathy examinations in premature infants. A total of 84 infants with a gestational age of less than 34 weeks will be randomly assigned to one of the two groups. The study will assess pain levels using video recordings and physiological indicators before, during, and after the examination. The goal is to determine which positioning method is more effective in alleviating pain during this critical procedure.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for premature infants undergoing eye examinations.
How similar studies have gone: While the specific approach of reverse kangaroo care in this context may be novel, similar non-pharmacological methods have shown promise in managing pain in other pediatric settings.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Gestational age \<34 weeks, * Birth weight ≤ 2500 grams, * No painful interventions at least 1 hour before the ROP examination, * Fed at least 1 hour before the ROP examination, * Premature infants whose parents consented to participate in the study. Exclusion Criteria: * Having a condition that prevents pain assessment (intracranial hemorrhage, neuromotor developmental delay etc.) * Any congenital anomaly (eye, neurological, etc.), * Have a diagnosed hearing problem, * A different painful procedure was performed at least one hour before the ROP examination, * Administration of an analgesic/sedative medication before the examination, * Premature infants whose parents did not consent to participate in the study.
Where it's running
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Izmır Provincial Health Directorate Bakircay University Cigli Regional Educational Hospital
Izmir, Menemen, Turkey (Türkiye) Recruiting
Study contacts
- Principal investigator: Hatice Bal Yılmaz, Prof. Dr. — Ege University
- Study coordinator: Sinem Başdemir, Research Assistant
- Email: sinem.basdemir@bakircay.edu.tr
- Phone: +905550074974
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Imaging retinal structure in premature babies to guide care
This study tests whether bedside ultra-widefield eye imaging can better guide treatment decisions for retinopathy of prematurity in preterm infants.
-
Does early red blood cell transfusion affect complications and neurodevelopment in premature infants?
This study tests whether giving blood transfusions in the first month of life in premature babies is linked to early complications like ROP, NEC, BPD, IVH, and to later neurodevelopmental outcomes.
-
Testing FLQ-101 for retinopathy of prematurity in very premature newborns
This will test whether giving FLQ-101 to very premature babies (born at 26+0 to 27+6 weeks and weighing ≥650 g) is safe and produces the expected drug effects in their bodies.
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Low-dose Conbercept treatment for Retinopathy of Prematurity
This study is testing if a low-dose eye treatment called Conbercept can help preterm infants with Retinopathy of Prematurity feel better and improve their vision.
-
New imaging technology for diagnosing retinopathy of prematurity in infants
This study is testing a new imaging technology to help doctors better see and understand eye problems in premature infants with retinopathy of prematurity.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.