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REDEXAM
Reducing Painful Eye Examinations in Preterm Infants
Sponsor study identifier
observational
500
1 country
1
Study Start
November 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2015
Actual (reported)Study Completion
July 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 20, 2013
Actual (reported)May 23, 2013
Actual (reported)November 2013
Date type not reportedThis date has not been verified as actual or estimated.
July 2015
Actual (reported)July 2015
Actual (reported)the ability of urinary NTproBNP (normalised to creatinine) at 14 days of age and 28 days to predict severity of ROP
day 14 and day 28
Receiver operator characteristics curve, sensitivity, specificity, positive and negative predictive values.
day 14 and day 28
all \<32 weeks
Preterm infants \<1500g or \<32 weeks gestation
Janet Berrington, Newcastle Neonatal Service
Newcastle, Tyne and Wear, NE1 4LP, United Kingdom
Urine
Janet Berrington, MD
Newcastle-upon-Tyne Hospitals NHS Trust
500 participants (actual enrollment reported by the registry).
First Submitted
May 20, 2013
First Posted
May 23, 2013
Study Start
November 2013
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
July 2015
Actual (reported)Study Completion
July 2015
Actual (reported)Last Updated
October 12, 2015
Record last verified: 2015-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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