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Pain in Neonates During Screening for Retinopathy of Prematurity Using Two Methods

Pain in Neonates During Screening for Retinopathy of Prematurity Using Binocular Indirect Ophthalmoscopy and Wide-field Digital Retinal Imaging: a Randomized Comparison

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00895869
Acronym
RETCAM
Enrollment
76
Registered
2009-05-08
Start date
2004-04-30
Completion date
2008-02-29
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Retinopathy of Prematurity

Keywords

Screening, Retinopathy, Prematurity, Pain

Brief summary

Retinopathy of prematurity screening is painful. Wide field digital retinal imaging (WFDRI) and binocular indirect ophthalmoscopy (BIO) are being used for screening examinations. The aim of Edinburgh, UK based study is to compare the pain experienced by infants using both examination techniques.

Detailed description

Infants undergoing routine eye screening at Edinburgh Royal Infirmary Neonatal Intensive Care Unit are to be recruited. Infants will be excluded if they require mechanical ventilation or analgesic medication or if they have moderate/severe neurological impairment. The first screening examination for each baby was included. Infants' eyes will be examined by both WFDRI and BIO with eyelid speculum by 2 experienced pediatric ophthalmologists in random order. Observations will be video-recorded during examinations to generate a pain score (premature infant pain profile) for both WFDRI and BIO. The pain scores, heart rates, oxygen saturations and time taken for WFDRI and BIO will be compared using paired t tests.

Interventions

None listed

Sponsors

NHS Lothian
Lead SponsorOTHER_GOV

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 32 Weeks
Healthy volunteers
No

Inclusion criteria

* Infants born at less than 32 weeks gestation and/or birth weight of less than 1500g.

Exclusion criteria

* Infants requiring mechanical ventilation * Infants requiring analgesic medication * Infants with moderate/sever neurological impairment

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026