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BiHiVE2 Study. The Investigation and Validation of Predictive Biomarkers in Hypoxic-ischaemic Encephalopathy.

NCT02019147 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2018-07-06

No results posted yet for this study

Summary

Despite recent advances in the care of mothers and newborn infants, many infants (approximately 20 per 1000 live births) continue to need resuscitation at birth. A proportion of these infants will have sustained significant injury through interruption of their blood and oxygen supply prior to delivery (perinatal asphyxia). In 2-3 babies per 1000 this will lead to brain swelling and the risk of long term brain injury called neonatal hypoxic-ischaemic encephalopathy (HIE). HIE remains a cause of neonatal death and long term disability. Early and accurate prediction of outcome would allow us to intervene during the window of the first 6 hours following birth, prior to secondary reperfusion and secondary brain injury. Estimating severity of injury can be difficult in newborn infants. Condition at birth does not predict neonatal, or longer term outcome. Biomarkers which could be measured at the time of birth and analysed at the bedside would offer these infants the best chance of timely and effective intervention. Through the BIHIVE study we have identified a number of predictive biomarkers in hypoxic-ischaemic encephalopathy. These markers are present in umbilical cord blood and have been identified through proteomic and metabolomic analysis of a stored biobank of samples from a recruited cohort of infants with perinatal asphyxia and hypoxic-ischaemic encephalopathy. We now wish to validate these biomarkers in an additional cohort, and will continue to explore new biomarkers in our stored biobank of umbilical cord samples. In addition we wish to assess our ability to predict neurodevelopmental and behavioural outcome in these infants. In this way we will determine the most robust biochemical and clinical markers for the prediction of early and medium term outcome in HIE. This study will establish the evidence base and validation of these biomarkers to the point where they can be developed into a bedside diagnostic algorithm which can be used in the labour ward to immediately identify those infants at risk of HIE in time to prevent secondary damage.

Conditions

  • Hypoxic Ischaemic Encephalopathy (HIE)
  • Asphyxia

Sponsors & Collaborators

Principal Investigators

  • Deirdre Murray, MD · University College Cork, Ireland

Eligibility

Max Age
1 Hour
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • Ireland
  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02019147 on ClinicalTrials.gov