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

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.

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Key information

Conditions

Retinopathy of Prematurity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Neurologic Manifestations Obstetric Labor Complications Obstetric Labor, Premature Pain Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Retinal Diseases Signs and Symptoms Urogenital Diseases

Age range

Up to 32 week

Sex eligibility

All sexes

Study type

Observational

Primary location

NHS Lothian

Edinburgh, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

NHS Lothian

Other Gov

Registry information

Official study title

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

Acronym: RETCAM

Important dates

Study start: 2004
Primary completion: 2008
Study completion: 2008
First posted: May 8, 2009
Registry last updated: Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed