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

Completed

• Conditions: Retinopathy of Prematurity; Pain

• Registration Number: NCT00895869
• Lead Sponsor: NHS Lothian

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.

Study Timeline

• Study Start: 2004-04
• Primary Completion: 2008-01
• Study Completion: 2008-02
• Study First Submitted: 2009-05-07
• Study First Submitted QC: 2009-05-07
• Study First Posted: 2009-05-08
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-24
• Last Update Posted: 2010-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

NHS Lothian; 🇬🇧 Edinburgh, United Kingdom