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NCT00895869 Clinical Trial

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

Pain Clinical Trial

— RETCAM  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00895869
Other study ID # BF01
Secondary ID JB001RF001
Status Completed
Phase N/A
First received May 7, 2009
Last updated February 24, 2010
Start date April 2004
Est. completion date February 2008

Study information
Verified date February 2010
Source NHS Lothian
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 76
Est. completion date February 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Both
Age group N/A to 32 Weeks
Eligibility 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

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom NHS Lothian Edinburgh

Sponsors (1)
Lead Sponsor Collaborator
NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

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