REDEXAM - Reducing Painful Eye Examinations in Preterm Infants

NCT01861470 | Completed

• 1 other identifier: 6650
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinopathy of Prematurity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Receiver operator characteristics curve, sensitivity, specificity, positive and negative predictive values.

  day 14 and day 28

Study Arms (1)

Preterm infants

all \<32 weeks

Eligibility Criteria

• Age: Up to 56 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Preterm infants \<1500g or \<32 weeks gestation

You may qualify if:

• Preterm infants \<1500g or \<32 weeks gestation

You may not qualify if:

• Separate ocular pathology

Sponsors & Collaborators

• Newcastle-upon-Tyne Hospitals NHS Trust: lead

Study Sites (1)

Janet Berrington, Newcastle Neonatal Service

Newcastle, Tyne and Wear, NE1 4LP, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

MeSH Terms

Conditions

Retinopathy of Prematurity

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Janet Berrington, MD

  Newcastle-upon-Tyne Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2013
• First Posted: May 23, 2013
• Study Start: November 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 12, 2015

Record last verified: 2015-10

Locations

GB (1)