Stress Induced by Screening for Retinopathy of Prematurity – Should Speculum and Indentation Rather be Avoided

Brief Title

Stress Induced by Screening for Retinopathy of Prematurity - Should Speculum and Indentation Rather be Avoided

Official Title

Stress Induced by Screening for Retinopathy of Prematurity - Should Speculum and Indentation Rather be Avoided

Brief Summary

      The purpose is to assess the hypothesis that indirect ophthalmoscopy for retinopathy of
      prematurity eye examination (ROPEE) screening without the use of a lid speculum and scleral
      indentation (speculum-free, SpF) is less painful/stressful than funduscopy with speculum (Sp)
      and scleral indentation.
    

Detailed Description

      A prospective randomized cross-over study was conducted for the comparison of the two
      techniques of funduscopy for ROPEE screening, i.e. with (Sp) or without (SpF) the use of a
      speculum and indentor. A random number table was used to allocate participants into either a)
      receiving Sp funduscopy on their first and SpF on their second screening examination a week
      later, or b) receiving SpF first and Sp a week later.
    

Study Type

Interventional

Primary Outcome

Premature Infant Pain Profile-Revised score (PIPP)

Secondary Outcome

 Crying score of the Bernese pain scale

Condition

Retinopathy of Prematurity

Intervention

Speculum-free (SpF) fundoscopy

Study Arms / Comparison Groups

 Study Group

Description:  ROPEE screening with speculum-free fundoscopy

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Other

Estimated Enrollment

37

Start Date

September 3, 2019

Completion Date

February 27, 2020

Primary Completion Date

February 4, 2020

Eligibility Criteria

        Inclusion Criteria:

        Preterm neonates undergoing screening for ROP, i.e.

          -  with GA < 32weeks and/or BW < 1501grams

          -  infants of greater BW and GA with increased comorbidity, e.g. sepsis, prolonged need
             for oxygen supplementation etc., as judged by the attending neonatologist

        Exclusion Criteria:

          1. Severe clinical condition with unstable vital signs to the extent that stress is not
             desired and the examination need to be postponed.

          2. Diagnosis of traumatic apoptosis of the corneal epithelium / corneal ulcer.

          3. Neonates under sedative/analgesic treatment.

          4. Intraventricular hemorrhage (III,IV degree), moderate/severe neurological impairment,
             other conditions that could alter pain response.
      

Gender

All

Ages

30 Weeks - 37 Weeks

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Greece

Location Countries

Greece

NCT ID

NCT04408807

Organization ID

414/08-05-2019

Responsible Party

Principal Investigator

Study Sponsor

Aristotle University Of Thessaloniki

Study Sponsor

, , 

Verification Date

March 2022