Neonatal Hypoxic Ischemic Encephalopathy:Early Diagnosis and Management of Comorbidities
Neonatal Hypoxic Ischemic Encephalopathy:Targeting Early Diagnosis and Management of Associated Comorbidities
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
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.
|
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.
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
3 weeks age.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
12 month
|
|
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.
|
1 month
|
|
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
|
1 month age
|
|
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.
|
12 month age
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Merchant N, Azzopardi D. Early predictors of outcome in infants treated with hypothermia for hypoxic-ischaemic encephalopathy. Dev Med Child Neurol. 2015 Apr;57 Suppl 3:8-16. doi: 10.1111/dmcn.12726.
- Bednarek N, Mathur A, Inder T, Wilkinson J, Neil J, Shimony J. Impact of therapeutic hypothermia on MRI diffusion changes in neonatal encephalopathy. Neurology. 2012 May 1;78(18):1420-7. doi: 10.1212/WNL.0b013e318253d589. Epub 2012 Apr 18.
- Pierrat V, Haouari N, Liska A, Thomas D, Subtil D, Truffert P; Groupe d'Etudes en Epidemiologie Perinatale. Prevalence, causes, and outcome at 2 years of age of newborn encephalopathy: population based study. Arch Dis Child Fetal Neonatal Ed. 2005 May;90(3):F257-61. doi: 10.1136/adc.2003.047985.
- Campbell O, Gipson R, el-Mohandes A, Issa AH, Matta N, Mansour E, Mohsen L. The Egypt National Perinatal/Neonatal Mortality Study 2000. J Perinatol. 2004 May;24(5):284-9. doi: 10.1038/sj.jp.7211084.
- El-Tallawy HN, Farghaly WM, Shehata GA, Metwally NA, Rageh TA, Abo-Elfetoh N. Epidemiology of cerebral palsy in El-Kharga District-New Valley (Egypt). Brain Dev. 2011 May;33(5):406-11. doi: 10.1016/j.braindev.2010.07.011. Epub 2010 Aug 24.
- Forman KR, Diab Y, Wong EC, Baumgart S, Luban NL, Massaro AN. Coagulopathy in newborns with hypoxic ischemic encephalopathy (HIE) treated with therapeutic hypothermia: a retrospective case-control study. BMC Pediatr. 2014 Nov 3;14:277. doi: 10.1186/1471-2431-14-277.
- Tao JD, Mathur AM. Using amplitude-integrated EEG in neonatal intensive care. J Perinatol. 2010 Oct;30 Suppl:S73-81. doi: 10.1038/jp.2010.93.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NHIE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.