Nephroprotection Following Perinatal Asphyxia: Randomized Controlled Trial

Effect of Pentoxyphylline in Nephroprotection Following Perinatal Asphyxia: Randomized Controlled Trial

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07088328

Enrollment

Registered

2025-07-28

Start date

2025-07-30

Completion date

2026-03-02

Last updated

2025-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxic-Ischemic Encephalopathy, Neonatal Encephalopathy, Pentoxifylline Adverse Reaction

Keywords

preterm infants, nephroprotection

Brief summary

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

DRUGPentoxifylline

Intravenous administration for 3 days

OTHERplacebo distilled water

Intravenous administration for 3 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Hours to 5 Days

Healthy volunteers

Inclusion criteria

Inclusion criteria: 1. Evidence of perinatal hypoxia, as indicated by at least one of the following: 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

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). \-

Design outcomes

Primary

Measure	Time frame	Description
Renal function	daily in the first 3 days of life.	creatinine level in mg/dl.

Secondary

Measure	Time frame	Description
Renal Doppler sonography	first 3 days of life	Peak systolic velocity (PSV) in cm/sec End diastolic velocity (EDV) in cm/sec.
cystatin C	first 24 hours of life	measure level using ng/L

Contacts

Primary ContactMarwa M Farag, PhD

d.marwa.farag@gmail.com01288681788

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026