Clinical trial Recruiting at 1 site Interventional Ages 28 Weeks to 33 Weeks

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 typeInterventional
Ages28 Weeks to 33 Weeks
SexAll
Enrollment84 (estimated)
SponsorEge University
Academic / other
Locations1 site (Izmir, Menemen)
StatusRecruiting
StartedFebruary 19, 2024
Main results expectedJune 30, 2025
Study endsJuly 30, 2025
Registry record updatedNovember 19, 2024
Trial IDNCT06694103 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

  • Izmır Provincial Health Directorate Bakircay University Cigli Regional Educational Hospital
    Izmir, Menemen, Turkey (Türkiye)
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.