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Neonatal Hypoxic Ischemic Encephalopathy:Early Diagnosis and Management of Comorbidities

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ClinicalTrials.gov Identifier: NCT03550612
Recruitment Status : Unknown
Verified June 2018 by ASAli, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : June 8, 2018
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
ASAli, Assiut University

Study Description
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Brief Summary:
Perinatal asphyxia is common cause of acquired neonatal brain injury in neonates associated with hypoxic-ischemic encephalopathy, leading to long-term neurologic complication or death. In 2000, the neonatal mortality rate in Egypt was found to be 25 per 1000 live birth. In this survey, hypoxic ischemic encephalopathy accounts for 18% of neonatal mortality and is the second most common cause of neonatal death.

Condition or disease Intervention/treatment
Neonatal Hypoxic Ischemic Encephalopathy Diagnostic Test: magnetic resonant imaging,cranial ultrasound. Diagnostic Test: Amplitude integrated electroencephalogram

Detailed Description:

Cerebral palsy as complication of hypoxic ischemic encephalopathy is common problem in Egypt.cerebral palsy is associated with many problems (cognitive disability-epilepsy-visual and hearing problems) that make great economic burden on their family and health care system. In 2010, the prevalence of cerebral palsy in El-Kharga District new valley described 2.04 cases of cerebral palsy every 1000 child.hypoxic ischemic encephalopathy was the second most common cause of cerebral palsy with prematurity the most common. 70.5% of children with cerebral palsy had severe mental retardation and 52% suffer from active epilepsy. An observational study on 224 cerebral palsy case from Tanta University found that 80.8% of patients with cerebral palsy had cognitive disorder, 36% had epilepsy, 25% loss of vision and 16% hearing problems. This health conditions provide a significant financial burden on the health system in Egypt.

There are two problems regard dealing with cases of hypoxic ischemic encephalopathy in Egypt, First one is early diagnosis and second is description of its severity. Assessment of the severity of cerebral injury and neurological outcome in infants with hypoxic ischemic encephalopathy is important for prognosis and stratifying the clinical management. Neurophysiological tests, including amplitude-integrated electroencephalogram , biochemical markers, and neuroimaging like (Trans cranial ultrasound - Magnetic resonance imaging) have been used to assess prognosis and predict long-term outcome. In our neonatal unit investigators perform routine cranial ultrasound to all cases of hypoxic ischemic encephalopathy.Cranial ultrasound is cheap, available, and easily performed bedside examination. However cranial ultrasound is limited in specificity and sensitivity in diagnosis of Hypoxic ischemic encephalopathy and prediction of prognosis.

Magnetic resonant imaging might provide the best information on structural brain lesions associated with long-term neurological impairment but is not available for immediate diagnostics on neonatal unit. Amplitude integrated electroencephalography is unfortunately not routinely performed in Egyptian neonatal units. It might improve early detection of Hypoxic ischemic encephalopathy and risk stratification accordingly.

Cerebral bleeding and infection are commonly described comorbidities in Hypoxic ischemic encephalopathy associated with the poor prognosis. Coagulopathy is common problem in asphyxiated infants. It is associated with asphyxia and therapeutic hypothermia (standardized treatment of hypoxia). Coagulopathy can cause bleeding in serious organs like brain that make the prognosis of Hypoxia bad and control of seizure difficult.

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Neonatal Hypoxic Ischemic Encephalopathy:Targeting Early Diagnosis and Management of Associated Comorbidities
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Neonates with hypoxic ischemic encephalopathy
Cranial ultrasound,Magnetic resonant imaging and amplitude integrated encephalogram performed to All neonates with hypoxic ischemic encephalopathy in period between January 2010 to December 2015.
 Diagnostic Test: magnetic resonant imaging,cranial ultrasound.
Magnetic resonant image performed at term gestation neonate suffer of hypoxic ischemic encephalopathy and its results will be analysed in details and classified according to global score of magnetic resonant image injury.Cranial ultrasound results will be analysed regards (periventricular - interventricular haemorrhage-Ventricular size-basal ganglia, thalamus and cerebellum affection) and Doppler (peak systolic flow velocity-end diastolic peak flow velocity-mean velocity and resistance index).Cerebral bleeding will be diagnosed be cranial ultrasound and confirmed be standard magnetic resonant image in term equivalent age.

Diagnostic Test: Amplitude integrated electroencephalogram

Amplitude integrated electroencephalogram before and during cooling will be assessed and classified according to Hellstrom Westas et al 2006 and it will be compared with the results of cranial ultrasound and magnetic resonant imaging.

Neurodevelopment study at 12 and 14 month age using Bayley ɪɪɪ score will be compared with the results of cranial ultrasound,magnetic resonant imaging and Amplitude integrated electroencephalogram.


Outcome Measures
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Primary Outcome Measures :
  1. Compare results of cranial ultrasound with Magnetic resonant imaging to improve quality of cranial ultrasound to early diagnosis of hypoxic ischemic encephalopathy [ Time Frame: 3 weeks age. ]
    Cranial ultrasound results will be analysed regards (periventricular - interventricular haemorrhage-Ventricular size-basal ganglia, thalamus and cerebellum affection) and Doppler (peak systolic flow velocity-end diastolic peak flow velocity-mean velocity and resistance index).magnetic resonant imaging performed at term gestation results will be analysed in details and classified according to global score of magnetic resonant imaging injury (mild, moderate and severe injury) and compare it with results of cranial ultrasound


Secondary Outcome Measures :
  1. Detect incidence of intracranial haemorrhage in asphyxiated newborn treated by therapeutic hypothermia. [ Time Frame: 12 month ]
    Analysis of perinatal risk factors associated with increase incidence of intracranial hemorrhage.and coagulation limits after that intracranial haemorrhage occurs and transfusion limits decrease incidence of intracranial haemorrhage.

  2. Detection of associated infection in asphyxiated newborn treated by therapeutic hypothermia. [ Time Frame: 1 month ]
    Detection of associated infection that increase seizure activity and make it difficult to control.C-reactive protein and blood culture will be the gold standard to diagnosis associated infection, suspicious sepsis on C-reactive protein ≥ 10 and confirmed by blood culture.

  3. Ability of cranial ultrasound in early diagnosis of intracranial haemorrhage. [ Time Frame: 1 month age ]
    By compare results of cranial ultrasound with standard magnetic resonant imaging

  4. Compare results of diagnostic methods of hypoxic ischemic encephalopathy with neurodevelopmental study of the baby at 12 month [ Time Frame: 12 month age ]
    Compare results of magnetic resonant imaging,Cranial ultrasound and amplitude integrated encephalogram in babies with Hypoxic ischemic encephalopathy undergoes therapeutic cooling with neurodevelopmental score at 12 month age.


Eligibility Criteria
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Ages Eligible for Study:   up to 6 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
all neonates with hypoxic ischemic encephalopathy treated by therapeutic hypothermia 6 hours after birth in period between January 2010 to December 2015.One hundred cases will be included in the study as fifteen to twenty case of HIE admitted for therapeutic hypothermia treatment at the hospital every year.
Criteria

Inclusion Criteria:

  • >36 weeks gestational age babies undergoes therapeutic hypothermia within 6 hours after birth after fulfilling the cooling criteria:
  • Apgar score ≤ 5 at 10 minutes after birth.
  • Need resuscitation 10 minutes after birth.
  • Acidosis PH≤7 at 60 minutes.
  • Base deficit ≥16 mmoL ∕ L at 60 minutes.

Exclusion Criteria:

  • Birth weight ≤1.8kg.
  • Congenital and genetic conditions affect neurodevelopment.
Contacts and Locations
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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): NCT03550612


Contacts
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Contact: Prof.Samia A Mohamed, MD 00201223971326 samiaatwa@gmail.com
Contact: dr Safwat M Abdel-Aziz, MD 00201003918080 Drsefwat90@yahoo.com

Sponsors and Collaborators
Assiut University
More Information
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Publications:

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Responsible Party: ASAli, Principle investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03550612    
Other Study ID Numbers: NHIE
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Diseases
Brain Ischemia
Hypoxia-Ischemia, Brain
Ischemia
Hypoxia
Pathologic Processes
Central Nervous System Diseases
 Nervous System Diseases
Signs and Symptoms, Respiratory
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain