Nephroprotection Following Perinatal Asphyxia: Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pentoxifylline, placebo distilled water.
- Who it may be relevant to
- Registry conditions: Hypoxic-Ischemic Encephalopathy, Neonatal Encephalopathy, Pentoxifylline Adverse Reaction. Basic parameters: 1 Hour — 5 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of Pentoxyphylline in Nephroprotection Following Perinatal Asphyxia: Randomized Controlled Trial
Overview
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.
Interventions
- Drug Pentoxifylline
Intravenous administration for 3 days - Other placebo distilled water
Intravenous administration for 3 days
Primary outcome measures
- Renal function [Time frame: daily in the first 3 days of life.]
Secondary outcome measures (2)
- Renal Doppler sonography [Time frame: first 3 days of life]
- cystatin C [Time frame: first 24 hours of life]
Eligibility criteria
Inclusion criteria
Inclusion criteria
- Evidence of perinatal hypoxia, as indicated by at least one of the following:
- Apgar score of less than or equal to 5 at 10 minutes.
- ongoing resuscitation at 10 minutes.
- 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.
- 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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07088328 · 0108348