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

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ClinicalTrials.gov Identifier: NCT02019147
Recruitment Status : Completed
First Posted : December 24, 2013
Last Update Posted : July 6, 2018
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Dr. Deirdre Murray, University College Cork

Brief 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.

Condition or disease
Hypoxic Ischaemic Encephalopathy (HIE) Asphyxia

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Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: BiHiVE 2 Study. The Investigation and Validation of Predictive Biomarkers in Hypoxic-ischaemic Encephalopathy.
Study Start Date : March 2012
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Group/Cohort
Term Hypoxic Ischaemic Encephalopathy
Term Hypoxic Ischaemic Encephalopathy (HIE)
Healthy Term Neonates
Controls



Primary Outcome Measures :
  1. EEG confirmed hypoxic-ischaemic brain injury in the first 72 hours of life [ Time Frame: 24 hours ]
    Clinical examination using the Thompson Encephalopathy score and visual interpretation of multichannel EEG


Secondary Outcome Measures :
  1. Neurodevelopmental outcome at 2 years of age assessed using BSID III [ Time Frame: 18-24 months ]
    Bayley's Scales of infant Development Version III


Biospecimen Retention:   Samples With DNA
Umbilical cord blood


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Ages Eligible for Study:   up to 1 Hour   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Term Neonates born in hospital
Criteria

Inclusion Criteria:

Term infants defined at greater than 36 weeks gestation

All infants with one or more of the following clinical markers of HIE:

Apgar score less than or equal to 6 at 5 minutes pH < 7.1 on cord blood, Requiring intubation or CPR at birth -

Exclusion Criteria:

Outborn babies Less than 36 weeks gestation

-


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 ClinicalTrials.gov identifier (NCT number): NCT02019147


Locations
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Ireland
Cork University Maternity Hospital
Cork, Ireland, 00000
Sweden
Karolinska University Hospital
Stockholm, Sweden
Sponsors and Collaborators
University College Cork
Karolinska Institutet
Investigators
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Principal Investigator: Deirdre Murray, MD University College Cork, Ireland
Additional Information:
Publications of Results:

Other Publications:
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Responsible Party: Dr. Deirdre Murray, Senior Lecturer, Consultant Paediatrician, University College Cork
ClinicalTrials.gov Identifier: NCT02019147    
Other Study ID Numbers: DM0113UCC
First Posted: December 24, 2013    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018
Keywords provided by Dr. Deirdre Murray, University College Cork:
HIE
Biomarker
Additional relevant MeSH terms:
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Brain Diseases
Brain Ischemia
Hypoxia-Ischemia, Brain
Ischemia
Hypoxia
Asphyxia
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain
Death
Wounds and Injuries