REDEXAM - Reducing Painful Eye Examinations in Preterm Infants

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Newcastle-upon-Tyne Hospitals NHS Trust
Sponsor:
Information provided by (Responsible Party):
Janet Berrington, Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01861470
First received: May 20, 2013
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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
Retinopathy of Prematurity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reducing Painful Eye Examinations in Preterm Infants

Resource links provided by NLM:


Further study details as provided by Newcastle-upon-Tyne Hospitals NHS Trust:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Receiver operator characteristics curve, sensitivity, specificity, positive and negative predictive values. [ Time Frame: day 14 and day 28 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Urine


Estimated Enrollment: 315
Study Start Date: November 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Preterm infants

  Eligibility

Ages Eligible for Study:   up to 56 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Preterm infants <1500g or <32 weeks gestation

Criteria

Inclusion Criteria:

  • Preterm infants <1500g or <32 weeks gestation

Exclusion Criteria:

  • Separate ocular pathology
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01861470

Locations
United Kingdom
Janet Berrington, Newcastle Neonatal Service Recruiting
Newcastle, Tyne and Wear, United Kingdom, NE1 4LP
Contact: janet Berrington       j.e.berrington@ncl.ac.uk   
Principal Investigator: Janet Berrington         
Sponsors and Collaborators
Janet Berrington
  More Information

No publications provided

Responsible Party: Janet Berrington, Consultant Neonatal Paediatrician, Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01861470     History of Changes
Other Study ID Numbers: 6650
Study First Received: May 20, 2013
Last Updated: February 3, 2014
Health Authority: United Kingdom: National Health Service

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

ClinicalTrials.gov processed this record on August 21, 2014