Nephroprotection Following Perinatal Asphyxia: Randomized Controlled Trial
NCT ID: NCT07088328
Last Updated: 2025-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2025-07-30
2026-03-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Pentoxifylline group
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
Pentoxifylline
Intravenous administration for 3 days
Control group
They will not be given pentoxifylline as reno-protective drug
placebo distilled water
Intravenous administration for 3 days
Interventions
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Pentoxifylline
Intravenous administration for 3 days
placebo distilled water
Intravenous administration for 3 days
Eligibility Criteria
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Inclusion Criteria
1. Apgar score of less than or equal to 5 at 10 minutes.
2. ongoing resuscitation at 10 minutes.
3. pH less than 7.14 or a base deficit worse than or equal to minus 12 mmol/L on cord/arterial/venous/capillary blood gas obtained within 60 minutes of birth.
2. Evidence of moderate to severe encephalopathy using Sarnat staging score.(14)
3. Greater than or equal to 35 weeks gestational age.
4. Birth weight greater than or equal to 1800 g.
Exclusion Criteria
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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1 Hour
5 Days
ALL
No
Sponsors
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Alexandria University
OTHER
Responsible Party
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Marwa Mohamed Farag
Assistant professor of Pediatrics
Central Contacts
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Other Identifiers
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0108348
Identifier Type: -
Identifier Source: org_study_id
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