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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00895869
Recruitment Status : Completed
First Posted : May 8, 2009
Last Update Posted : February 25, 2010
Sponsor:
Information provided by:

Study Description
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.

Condition or disease
Retinopathy of Prematurity Pain

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 Design

Study Type : Observational
Actual Enrollment : 76 participants
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
Study Start Date : April 2004
Primary Completion Date : January 2008
Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Premature infants
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00895869


Locations
United Kingdom
NHS Lothian
Edinburgh, United Kingdom
Sponsors and Collaborators
NHS Lothian
Investigators
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

Responsible Party: Dr Tina Mclelland, R&D Governance Manager, NHS Lothian
ClinicalTrials.gov Identifier: NCT00895869     History of Changes
Other Study ID Numbers: BF01
JB001
RF001
First Posted: May 8, 2009    Key Record Dates
Last Update Posted: February 25, 2010
Last Verified: February 2010

Keywords provided by NHS Lothian:
Screening
Retinopathy
Prematurity
Pain

Additional relevant MeSH terms:
Retinal Diseases
Premature Birth
Retinopathy of Prematurity
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases