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

Retinopathy of Prematurity Clinical Trial

— stressROP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04408807
• Other study ID #: 414/08-05-2019
• Status: Completed
• Phase: N/A
• Start date: September 3, 2019
• Est. completion date: February 27, 2020

Study information

• Verified date: March 2022
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: February 27, 2020
• Est. primary completion date: February 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Weeks to 37 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

Other:
• Speculum-free (SpF) fundoscopy
Indirect ophthalmoscopy without the use of eyelid speculum and scleral indentation
• Speculum (Sp) fundoscopy
Indirect ophthalmoscopy with the use of eyelid speculum and scleral indentation

Locations

Country	Name	City	State
Greece	"Papageorgiou" Hospital	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

References & 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. — View 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. — View 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 — View 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. Epub 2004 Dec 8. — View 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. Epub 2006 Jul 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Crying score of the Bernese pain scale		During the examination
Secondary	Adverse events including arrythmia/bradycardia, apnoea, increased oxygen demands and feed intolerance		During the examination and during the 24 hours after the examination
Secondary	Adequacy of judging the presence of treatment-requiring ROP		At the end of ROPEE screening
Secondary	Duration of fundoscopy		During the examination