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

NCT ID: NCT00895869

Last Updated: 2024-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-04-30

Study Completion Date

2008-02-29

Brief Summary

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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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Detailed Description

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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.

Conditions

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Retinopathy of Prematurity Pain

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NHS Lothian

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr B Fleck, MBChB FRCOpth BSc(Hons) MD

Role: STUDY_CHAIR

NHS Lothian

Dr C Dhaliwal, BSc(Hons) MBChB MRCPCH

Role: PRINCIPAL_INVESTIGATOR

NHS Lothian

Locations

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NHS Lothian

Edinburgh, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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JB001

Identifier Type: -

Identifier Source: secondary_id

RF001

Identifier Type: -

Identifier Source: secondary_id

BF01

Identifier Type: -

Identifier Source: org_study_id

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