NCT03550612

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 8, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

June 26, 2018

Status Verified

June 1, 2018

Enrollment Period

1 year

First QC Date

May 28, 2018

Last Update Submit

June 22, 2018

Conditions

Neonatal Hypoxic Ischemic Encephalopathy

Outcome Measures

Primary Outcomes (1)

  • Compare results of cranial ultrasound with Magnetic resonant imaging to improve quality of cranial ultrasound to early diagnosis of hypoxic ischemic encephalopathy

    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 Outcomes (4)

  • Detect incidence of intracranial haemorrhage in asphyxiated newborn treated by therapeutic hypothermia.

    12 month

  • Detection of associated infection in asphyxiated newborn treated by therapeutic hypothermia.

    1 month

  • Ability of cranial ultrasound in early diagnosis of intracranial haemorrhage.

    1 month age

  • Compare results of diagnostic methods of hypoxic ischemic encephalopathy with neurodevelopmental study of the baby at 12 month

    12 month age

Study Arms (1)

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.Diagnostic Test: Amplitude integrated electroencephalogram

Interventions

magnetic resonant imaging,cranial ultrasound.DIAGNOSTIC_TEST

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.

Neonates with hypoxic ischemic encephalopathy
Amplitude integrated electroencephalogramDIAGNOSTIC_TEST

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.

Neonates with hypoxic ischemic encephalopathy

Eligibility Criteria

AgeUp to 6 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • \>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.

You may not qualify if:

  • Birth weight ≤1.8kg.
  • Congenital and genetic conditions affect neurodevelopment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 15846019BACKGROUND

  • 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.

    PMID: 15042109BACKGROUND

  • 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.

    PMID: 20797827BACKGROUND

  • 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.

    PMID: 25800487BACKGROUND

  • 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.

    PMID: 25367591BACKGROUND

  • 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.

    PMID: 22517107BACKGROUND

  • 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.

    PMID: 20877412BACKGROUND

Central Study Contacts

Prof.Samia A Mohamed, MD

CONTACT

00201223971326samiaatwa@gmail.com

dr Safwat M Abdel-Aziz, MD

CONTACT

00201003918080Drsefwat90@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

May 28, 2018

First Posted

June 8, 2018

Study Start

February 1, 2019

Primary Completion

February 1, 2020

Study Completion

December 1, 2020

Last Updated

June 26, 2018

Record last verified: 2018-06