Pain in Neonates During Screening for Retinopathy of Prematurity Using Two Methods
- Conditions
- Retinopathy of PrematurityPain
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
- Infants born at less than 32 weeks gestation and/or birth weight of less than 1500g.
- Infants requiring mechanical ventilation
- Infants requiring analgesic medication
- Infants with moderate/sever neurological impairment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
NHS Lothian
🇬🇧Edinburgh, United Kingdom