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

Aristotle University Of Thessaloniki

Status

Completed

Conditions

Retinopathy of Prematurity

Treatments

Other: Speculum (Sp) fundoscopy

Other: Speculum-free (SpF) fundoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT04408807

414/08-05-2019

Details and patient eligibility

About

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.

Full 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.

Enrollment

37 patients

Sex

All

Ages

30 to 37 weeks old

Volunteers

No Healthy Volunteers

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.