Nephroprotection Following Perinatal Asphyxia: Randomized Controlled Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-5
SponsorAlexandria University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Pentoxifylline
DrugIntravenous administration for 3 days
placebo distilled water
Other interventionIntravenous administration for 3 days
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Pentoxifylline groupActive comparator 1 intervention
Group B: Control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Renal function
creatinine level in mg/dl.
Time frame
daily in the first 3 days of life.Secondary outcomes
1
Renal Doppler sonography
Peak systolic velocity (PSV) in cm/sec End diastolic velocity (EDV) in cm/sec.
Time frame
first 3 days of life2
cystatin C
measure level using ng/L
Time frame
first 24 hours of lifeLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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