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

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. Identifier: NCT01861470
Recruitment Status : Completed
First Posted : May 23, 2013
Last Update Posted : October 12, 2015
Information provided by (Responsible Party):
Newcastle-upon-Tyne Hospitals NHS Trust

Brief Summary:

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.

Condition or disease
Retinopathy of Prematurity

Detailed Description:
See protocol

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Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reducing Painful Eye Examinations in Preterm Infants
Study Start Date : November 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Preterm infants
all <32 weeks

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Receiver operator characteristics curve, sensitivity, specificity, positive and negative predictive values. [ Time Frame: day 14 and day 28 ]

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 56 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Preterm infants <1500g or <32 weeks gestation

Inclusion Criteria:

  • Preterm infants <1500g or <32 weeks gestation

Exclusion Criteria:

  • Separate ocular pathology

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 identifier (NCT number): NCT01861470

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United Kingdom
Janet Berrington, Newcastle Neonatal Service
Newcastle, Tyne and Wear, United Kingdom, NE1 4LP
Sponsors and Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
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Principal Investigator: Janet Berrington, MD Newcastle-upon-Tyne Hospitals NHS Trust

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Responsible Party: Newcastle-upon-Tyne Hospitals NHS Trust Identifier: NCT01861470     History of Changes
Other Study ID Numbers: 6650
First Posted: May 23, 2013    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
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Retinopathy of Prematurity
Retinal Diseases
Eye Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases