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

This study has been completed.
Information provided by:
NHS Lothian Identifier:
First received: May 7, 2009
Last updated: February 24, 2010
Last verified: February 2010
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.

Retinopathy of Prematurity

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Pain in Neonates During Screening for Retinopathy of Prematurity Using Binocular Indirect Ophthalmoscopy and Wide-field Digital Retinal Imaging: a Randomized Comparison

Resource links provided by NLM:

Further study details as provided by NHS Lothian:

Enrollment: 76
Study Start Date: April 2004
Study Completion Date: February 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   up to 32 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Premature infants

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00895869

United Kingdom
NHS Lothian
Edinburgh, United Kingdom
Sponsors and Collaborators
NHS Lothian
Study Chair: Dr B Fleck, MBChB FRCOpth BSc(Hons) MD NHS Lothian
Principal Investigator: Dr C Dhaliwal, BSc(Hons) MBChB MRCPCH NHS Lothian
  More Information

No publications provided

Responsible Party: Dr Tina Mclelland, R&D Governance Manager, NHS Lothian Identifier: NCT00895869     History of Changes
Other Study ID Numbers: BF01, JB001, RF001
Study First Received: May 7, 2009
Last Updated: February 24, 2010
Health Authority: United Kingdom: National Health Service

Keywords provided by NHS Lothian:

Additional relevant MeSH terms:
Retinal Diseases
Retinopathy of Prematurity
Eye Diseases
Infant, Newborn, Diseases
Infant, Premature, Diseases processed this record on November 25, 2015