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Not yet recruitingNCT06694545Updated Nov 19, 2024

Neonates With Hypoxic Ischemic Encephalopathy (HIE)

An observational study in Hypoxic Ischemic Encephalopathy (HIE), sponsored by Assiut University. Not yet recruiting. Open to participants aged 1 Day to 28 Days. Per ClinicalTrials.gov, last updated 2024-11-19.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
72
Ages
1 Day to 28 Days
Sex
All
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Study 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

Read the detailed description

Encephalopathy in neonates is broadly defined as 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.

Perinatal asphyxia is a condition where hypoxaemia and acidosis are present in the fetus or the newborn infants. It is a failure newborn to initiate spontaneous, sustained, and vigorous respiration effort at birth. It is also defined as a failure to initiate spontaneous respirations and/or a 5-minute Apgar score of less than 7: the most commonly used indicator in the identification of birth asphyxia in resource limited settings . About 20% - 30% of asphyxiated newborns who develop hypoxic ischemic encephalopathy (HIE) die during the neonatal period, and one third to one half of survivors are left with cerebral palsy and mental retardation . Survivors present with several short and long term morbidities, including: seizure disorders, tone abnormalities, feeding difficulties, delayed developmental milestones, learning difficulties, cerebral palsy and mental retardation. The frequency of severe perinatal asphyxia complications, hypoxic ischemic encephalopathy (HIE) and incidence of up to 26.5/1000 live births is unacceptably high despite advances in perinatal care . Encephalopathy occurs in 50% to 60% of patients with severe perinatal asphyxia. Among patients with moderate HIE, 10% to 20% die, and 30% to 40% develop neurodevelopmental disorders, whereas 50% of patients with severe HIE die and almost all survivors develop neurodevelopmental deficits Neuro-science research has revealed our understanding of the mechanisms by perinatal asphyxia neuronal damage and adverse consequences. Asphyxia leads to two types of cerebral injuries: the primary neuronal injury that occurs at the time of hypoxic-ischemic insults and the secondary cerebral injury that occurs over hours to days after accumulation of excessive intra-neuronal calcium through stimulation of the excitatory N-methyl-D-aspartate (NMDA) glutamate receptors, which triggers apoptosis of the affected neurons . Magnesium is a naturally occurring NMDA receptor antagonist that blocks neuronal influx of calcium within the ion channels. This block is voltage-dependent and is overcome during axonal depolarization that occurs in hypoxic-ischemic insults. If the extra-cellular magnesium concentration is increased, this blockade can be restored. Magnesium sulphate may also have direct actions on mitochondrial activity, anticonvulsant properties and hemodynamic effects by increasing cerebral blood flow. Some data also suggest that MgSO4 may serve an anti-apoptotic role and prevent neuronal cell loss .

Clinical studies have shown that caffeine also has neuroprotective effects in premature infants by alleviating hypoxia induced white matter damage, and improving ventilation function and brain self-regulation In addition, caffeine has been shown to reduce the apoptosis of developing brain neurons, ventricular enlargement, and white matter loss caused by hypoxia.

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Conditions studied

  • Hypoxic Ischemic Encephalopathy (HIE)
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In context

Hypoxia-Ischemia, Brain

241 studies on the registry are indexed under Hypoxia-Ischemia, Brain; 85 are open to participants now.

This study's planned enrollment of 72 is below the median of 100 across 88 observational studies indexed under Hypoxia-Ischemia, Brain.

Browse Hypoxia-Ischemia, Brain studies →

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Day to 28 Days
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Neonates with Apgar's score > 3 at 5 min
  2. Neonates with congenital malformations
  3. Neonates whose mother had general anasthesia
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
72 participants (estimated)
Patient registry
No
06

What researchers measure

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.

    Time frame: Baseline

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 16631096 ↗
  • 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. PubMed 31450231 ↗
  • Volpe JJ. Neonatal encephalopathy: an inadequate term for hypoxic-ischemic encephalopathy. Ann Neurol. 2012 Aug;72(2):156-66. doi: 10.1002/ana.23647. PubMed 22926849 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06694545
Lead sponsor
Assiut University
Responsible party
Andrew Malak Zaki Malak (71515,Assiut, Assiut University) — Principal investigator
First posted
Nov 19, 2024
Start date
Dec 1, 2024 (estimated)
Primary completion
Dec 31, 2025 (estimated)
Completion
Jan 31, 2026 (estimated)
Last update
Nov 19, 2024

Study contacts

Andrew Malak Zaki
Contact
Andria.16266283@med.aun.edu.eg
01211843381
Gamal Ali Abd El-Aal
Contact
dr.gamalasker66@aun.edu.eg
01111686162

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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