Hypoxic ischemic encephalopathy. Hypoxic ischemic encephalopathy [HIE]
Conditions
Interventions
Intervention 1: Intervention group: newborns in the intervention group receive a single dose of Pentoxifylline at 5 mg/kg administered via gavage before initiation of therapeutic hypothermia. A 400 mg
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
1 Days to 1 Days
Inclusion criteria
Inclusion criteria: Gestational age = 36 weeks Birth weight = 1800 g Diagnosis of neonatal asphyxia grade II or III Diagnosis of moderate to severe hypoxic-ischemic encephalopathy (HIE) Ability to initiate therapeutic hypothermia within = 6 hours after birth
Exclusion criteria
Exclusion criteria: Presence of major congenital anomalies or known genetic syndromes Confirmed severe systemic infection Evidence of multi-organ failure at the time of study enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum lactate level. Timepoint: Baseline (before intervention), 12 hours, 24 hours, 48 hours, and 72 hours after initiation of therapeutic hypothermia. Method of measurement: Single Molecule Array (Simoa). | — |
Secondary
| Measure | Time frame |
|---|---|
| Neurodevelopmental outcomes. Timepoint: Neurodevelopmental assessment at 1 month of age; neurological changes and adverse events monitored from baseline until hospital discharge. Method of measurement: Bayley Scales of Infant and Toddler Development, Third Edition, and neurological changes including Sarnat score and amplitude integrated electroencephalography (aEEG). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHamideh Mazloumi
Iran University of Medical Sciences
Outcome results
None listed