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Completed

NCT Number: NCT04408807

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

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.

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Key information

Conditions

Retinopathy of Prematurity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Retinal Diseases

Age range

30 week–37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

"Papageorgiou" Hospital

Thessaloniki, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Severe clinical condition with unstable vital signs to the extent that stress is not desired and the examination need to be postponed.
  • Diagnosis of traumatic apoptosis of the corneal epithelium / corneal ulcer.
  • Neonates under sedative/analgesic treatment.
  • Intraventricular hemorrhage (III,IV degree), moderate/severe neurological impairment, other conditions that could alter pain response.

Treatment and study plan

Speculum-free (SpF) fundoscopy

Other

Indirect ophthalmoscopy without the use of eyelid speculum and scleral indentation

Speculum (Sp) fundoscopy

Other

Indirect ophthalmoscopy with the use of eyelid speculum and scleral indentation

Primary outcomes

  1. Premature Infant Pain Profile-Revised score (PIPP)

    Time frame: a) before the intervention [the effect of mydriasis (PIPP1)] b) at the end of the intervention [the effect of funduscopy (PIPP2)] c) 10-20 minutes after the intervention [the overall effect of the examination, i.e. mydriasis and funduscopy (PIPP3)]

Secondary outcomes

  1. Crying score of the Bernese pain scale

    Time frame: During the examination

  2. Adverse events including arrythmia/bradycardia, apnoea, increased oxygen demands and feed intolerance

    Time frame: During the examination and during the 24 hours after the examination

  3. Adequacy of judging the presence of treatment-requiring ROP

    Time frame: At the end of ROPEE screening

  4. Duration of fundoscopy

    Time frame: During the examination

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Acronym: stressROP

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 29, 2020
Registry last updated
Mar 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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