REDEXAM - Reducing Painful Eye Examinations in Preterm Infants (REDEXAM)

October 7, 2015 updated by: Newcastle-upon-Tyne Hospitals NHS Trust

Reducing Painful Eye Examinations in Preterm Infants

More than 8000 babies born >8 weeks early or weighing less than 1500g at birth in the United Kingdom annually are at risk of a serious eye problem - retinopathy of prematurity (ROP). Less than 1 in 10 need treating, but to identify these all of them require eye examinations 1-2 weekly from 5 weeks. These tests are uncomfortable, upsetting for families, and cost considerable time and money.

There is now a new urine test that might help identify babies with the highest risk of developing significant ROP. This cheap test appears to predict which babies need treatment and could avoid invasive eye examination in thousands of babies. The test has so far only been used in 136 babies. It accurately predicted ROP, but 136 babies cannot change practice. We need to test more babies including in the UK. This study is designed to test >300 UK babies to see how accurately urine levels of NTproBNP predict development of ROP needing treatment.

We will also pool our data with other researchers across Europe testing the same test to identify the best 'cut'-off' value for this test. In the future babies with urine levels of this chemical lower than this cut-off level would not need invasive eye examinations.

If this test works as we hope it will many babies will avoid repeated painful eye tests, and their families will be saved the stress of watching this being done, by replacing these with a simple easy cheap pain free urine test. There will be substantial savings in health care costs that could be used to improve other aspects of care. In resource poor settings without an expert ophthalmologist babies could be screened for ROP that currently cannot be screened.

We hope to demonstrate this to be a family-friendly, achievable intervention that positively impacts on the lives of babies and families experiencing neonatal intensive care.

Study Overview

Status

Completed

Conditions

Detailed Description

See protocol

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Tyne and Wear
      • Newcastle, Tyne and Wear, United Kingdom, NE1 4LP
        • Janet Berrington, Newcastle Neonatal Service

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Preterm infants <1500g or <32 weeks gestation

Description

Inclusion Criteria:

  • Preterm infants <1500g or <32 weeks gestation

Exclusion Criteria:

  • Separate ocular pathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Preterm infants
all <32 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the ability of urinary NTproBNP (normalised to creatinine) at 14 days of age and 28 days to predict severity of ROP
Time Frame: day 14 and day 28
day 14 and day 28

Secondary Outcome Measures

Outcome Measure
Time Frame
Receiver operator characteristics curve, sensitivity, specificity, positive and negative predictive values.
Time Frame: day 14 and day 28
day 14 and day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Newcastle-upon-Tyne Hospitals NHS Trust

Investigators

  • Principal Investigator: Janet Berrington, MD, Newcastle-upon-Tyne Hospitals NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

May 20, 2013

First Submitted That Met QC Criteria

May 22, 2013

First Posted (Estimate)

May 23, 2013

Study Record Updates

Last Update Posted (Estimate)

October 12, 2015

Last Update Submitted That Met QC Criteria

October 7, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6650

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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