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The aim of this study is to determine the value of Pentoxifylline for nephroprotection in these neonates with perinatal asphyxia, using cystatin C, regional oxygenation measured near infrared spectroscopy and renal Doppler sonography.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pentoxifylline group | Active Comparator | They will be given pentoxifylline as reno-protective drug (trentoximal, Egypharma ; E.D.A Reg.No.: 25276/2007) was administered intravenously to Neonates with perinatal hypoxia at 5mg/kg/hr given over 6 h daily for 3 consecutive days |
|
| Control group | Placebo Comparator | They will not be given pentoxifylline as reno-protective drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pentoxifylline | Drug | Intravenous administration for 3 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Renal function | creatinine level in mg/dl. | daily in the first 3 days of life. |
| Measure | Description | Time Frame |
|---|---|---|
| Renal Doppler sonography | Peak systolic velocity (PSV) in cm/sec End diastolic velocity (EDV) in cm/sec. | first 3 days of life |
| cystatin C | measure level using ng/L |
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Inclusion Criteria:
Inclusion criteria:
Evidence of perinatal hypoxia, as indicated by at least one of the following:
Evidence of moderate to severe encephalopathy using Sarnat staging score.(14)
Greater than or equal to 35 weeks gestational age.
Birth weight greater than or equal to 1800 g.
Exclusion Criteria:
Neonates with any of the following will be excluded:
1. Birth weight less than 1800 g. 2. Major congenital malformations/chromosomal anomalies including major cardiac anomalies. 3. Preterm less than 35 weeks gestational age according to modified Ballard score. (15) 4. progressive neuromuscular disorders (eg spinal muscle atrophy). 5. Severe systemic infections (eg TORCH infection).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marwa M Farag, PhD | Contact | 01288681788 | d.marwa.farag@gmail.com |
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| ID | Term |
|---|---|
| D020925 | Hypoxia-Ischemia, Brain |
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D010431 | Pentoxifylline |
| ID | Term |
|---|---|
| D013805 | Theobromine |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| placebo distilled water |
| Other |
Intravenous administration for 3 days |
|
| first 24 hours of life |
| D009422 | Nervous System Diseases |
| D002534 | Hypoxia, Brain |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |