Hypoxic Ischemic Encephalopathy Clinical Trial
Official title:
Acute Kidney Injury in Asphyxiated Infants Treated by Therapeutic Hypothermia
Verified date | April 2018 |
Source | Mansoura University Children Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study aims to determine the effect of therapeutic hypothermia on reducing AKI in term and late-preterm infants with hypoxic ischemic encephalopathy as estimated by measurment of serum(s) neutrophil gelatinase-associated lipocalin(NGAL) and serum (s) cystatin-C.
Status | Completed |
Enrollment | 30 |
Est. completion date | September 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 24 Hours |
Eligibility |
Inclusion criteria: 1. Full term newborn exposed to peri-natal asphyxia 2. Presented by signs of hypoxic ischemic encephalopathy (Sarnat grade II or III) Exclusion criteria: 1. Major intracranial haemorrhage 2. Birth weight less than 1800 g. 3. Major congenital anomalies including: 1. Chromosomal anomalies. 2. Congenital heart disease. 3. Congenital diaphragmatic hernia. 4. Congenital hydrocephalus and neural tube defects. 5. Intestinal atresia, tracheooesophageal fistulas, and omphalocele. |
Country | Name | City | State |
---|---|---|---|
Egypt | Mansoura University Children Hospital | Mansoura | El Dakahlya |
Lead Sponsor | Collaborator |
---|---|
Mansoura University Children Hospital |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acute kidney injury | A serum createnine-based modification of the Acute Kidney Injury Network criteria: Stage 0: No change in SCr, Stage 1:?SCr 0.3 mg/dL or ?SCr 150- <200% from previous trough value, Stage 2: ? SCr 200- <300% from previous trough value, Stage 3: ? SCr =300% from previous trough value, SCr 2.5 mg/dL, or dialysis |
15 days |
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