Neonates with Hypoxic Ischemic Encephalopathy (HIE)

NCT06694545 | Not Yet Recruiting

• 1 other identifier: Hypoxic IschemicEncephalopathy
• Study Type: observational
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

Assessment of the potential neuroprotective effect of magnesium sulphate and caffeine in treating asphyxiated newborns and improvement of the neurological outcome of Hypoxic Ischemic Encephalopathy in Assiut university hospital of Children

Conditions

Hypoxic Ischemic Encephalopathy (HIE)

Outcome Measures

Primary Outcomes (1)

• Assessment of the potential neuroprotective effect of magnesium sulphate and caffeine in improvement of the neurological outcome of hypoxic ischemic encephalopathy in Assuit university hospital.

  Assesment of neuroprotective effect of magnesium sulphate and caffeine by : 1. Determine the benefit of magnesium sulphate and caffeine on perinatal asphyxia. 2. Determine the effect of magnesium sulphate and caffeine on neurological outcome in severe perinatal Asphyxia. 3. Determine the effect of magnesium sulphate and caffeine on reduction of duration of Admission/hospitalization.

  Baseline

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonates with Hypoxic Ischemic Encephalopathy (HIE) .Encephalopathy in neonates is broadly defined brain dysfunction in a newborn manifesting as alteration in mental status and abnormal neurologic examination. Neonatal encephalopathy (NE) may result from acute or chronic hypoxic-ischemic injury, brain malformations, vascular injuries (including stroke), inborn errors of metabolism, and other causes. Hypoxic-ischemic encephalopathy (HIE) is a specific diagnosis and applies only when a neonate has encephalopathy that is known or highly suspected to be due to a hypoxic-ischemic event.

You may qualify if:

• Neonates with suspected perinatal asphyxia APGAR score \< 3 at 5 min.
• Neonates whose mother did not receive MgSO4 or caffeine

You may not qualify if:

• Neonates with Apgar's score \> 3 at 5 min
• Neonates with congenital malformations
• Neonates whose mother had general anasthesia

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• Azra Haider B, Bhutta ZA. Birth asphyxia in developing countries: current status and public health implications. Curr Probl Pediatr Adolesc Health Care. 2006 May-Jun;36(5):178-88. doi: 10.1016/j.cppeds.2005.11.002. No abstract available.

  PMID: 16631096 BACKGROUND

• Chalak L, Ferriero DM, Gressens P, Molloy E, Bearer C. A 20 years conundrum of neonatal encephalopathy and hypoxic ischemic encephalopathy: are we closer to a consensus guideline? Pediatr Res. 2019 Nov;86(5):548-549. doi: 10.1038/s41390-019-0547-9. Epub 2019 Aug 26. No abstract available.

  PMID: 31450231 BACKGROUND

• Volpe JJ. Neonatal encephalopathy: an inadequate term for hypoxic-ischemic encephalopathy. Ann Neurol. 2012 Aug;72(2):156-66. doi: 10.1002/ana.23647.

  PMID: 22926849 BACKGROUND

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Andrew Malak Zaki

CONTACT

01211843381; Andria.16266283@med.aun.edu.eg

Gamal Ali Abd El-Aal

CONTACT

01111686162; dr.gamalasker66@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 71515,Assiut

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: November 19, 2024
• Study Start: December 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: November 19, 2024

Record last verified: 2024-11