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

NCT04408807 | Completed

• 1 other identifier: 414/08-05-2019
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinopathy of Prematurity

Outcome Measures

Primary Outcomes (1)

• Premature Infant Pain Profile-Revised score (PIPP)

  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 (4)

• Crying score of the Bernese pain scale

  During the examination

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

  During the examination and during the 24 hours after the examination

• Adequacy of judging the presence of treatment-requiring ROP

  At the end of ROPEE screening

• Duration of fundoscopy

  During the examination

Study Arms (2)

Study Group

EXPERIMENTAL

ROPEE screening with speculum-free fundoscopy

Other: Speculum-free (SpF) fundoscopy

Control Group

ACTIVE COMPARATOR

ROPEE screening with speculum fundoscopy

Other: Speculum (Sp) fundoscopy

Interventions

Speculum-free (SpF) fundoscopy OTHER

Indirect ophthalmoscopy without the use of eyelid speculum and scleral indentation

Study Group

Speculum (Sp) fundoscopy OTHER

Indirect ophthalmoscopy with the use of eyelid speculum and scleral indentation

Control Group

Eligibility Criteria

• Age: 30 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

"Papageorgiou" Hospital

Thessaloniki, Greece

Location

Related Publications (5)

• 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.

  PMID: 19815939 BACKGROUND

• 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.

  PMID: 16828505 BACKGROUND

• 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.

  PMID: 15814220 BACKGROUND

• 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.

  PMID: 8120743 BACKGROUND

• 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.

  PMID: 34939742 RESULT

MeSH Terms

Conditions

Retinopathy of Prematurity

Interventions

Sun Protection Factor; Surgical Instruments

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Radiometry; Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Ophthalmology, Paediatric Ophthalmology and Strabismus

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: May 29, 2020
• Study Start: September 3, 2019
• Primary Completion: February 4, 2020
• Study Completion: February 27, 2020
• Last Updated: March 24, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)