Clinical trial NCT04408807: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinopathy of Prematurity
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 37
Sex: ALL
Minimum age (years): 30
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

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.

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.

Primary outcomes:
measure: Premature Infant Pain Profile-Revised score (PIPP)
timeFrame: 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:
measure: Crying score of the Bernese pain scale
timeFrame: During the examination
measure: Adverse events including arrythmia/bradycardia, apnoea, increased oxygen demands and feed intolerance
timeFrame: During the examination and during the 24 hours after the examination
measure: Adequacy of judging the presence of treatment-requiring ROP
timeFrame: At the end of ROPEE screening
measure: Duration of fundoscopy
timeFrame: During the examination
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: "Papageorgiou" Hospital
Study officials:
References:
citation: Dhaliwal CA, Wright E, McIntosh N, Dhaliwal K, Fleck BW. Pain in neonates during screening for retinopathy of prematurity using binocular indirect ophthalmoscopy and wide-field digital retinal imaging: a randomised comparison. Arch Dis Child Fetal Neonatal Ed. 2010 Mar;95(2):F146-8. doi: 10.1136/adc.2009.168971. Epub 2009 Oct 8.
citation: Mukherjee AN, Watts P, Al-Madfai H, Manoj B, Roberts D. Impact of retinopathy of prematurity screening examination on cardiorespiratory indices: a comparison of indirect ophthalmoscopy and retcam imaging. Ophthalmology. 2006 Sep;113(9):1547-52. doi: 10.1016/j.ophtha.2006.03.056. Epub 2006 Jul 7.
citation: Mehta M, Adams GG, Bunce C, Xing W, Hill M. Pilot study of the systemic effects of three different screening methods used for retinopathy of prematurity. Early Hum Dev. 2005 Apr;81(4):355-60. doi: 10.1016/j.earlhumdev.2004.09.005. Epub 2004 Dec 8.
citation: Dhillon B, Wright E, Fleck BW. Screening for retinopathy of prematurity: are a lid speculum and scleral indentation necessary? J Pediatr Ophthalmol Strabismus. 1993 Nov-Dec;30(6):377-81. doi: 10.3928/0191-3913-19931101-08.
citation: Mataftsi A, Lithoxopoulou M, Seliniotaki AK, Talimtzi P, Oustoglou E, Diamanti E, Soubasi V, Ziakas N, Haidich AB. Avoiding use of lid speculum and indentation reduced infantile stress during retinopathy of prematurity examinations. Acta Ophthalmol. 2022 Feb;100(1):e128-e134. doi: 10.1111/aos.15085. Epub 2021 Dec 23.