Nephroprotection Following Perinatal Asphyxia: Randomized Controlled Trial

Not Applicable

Not yet recruiting

• Conditions: Hypoxic-Ischemic Encephalopathy; Neonatal Encephalopathy; Pentoxifylline Adverse Reaction
• Interventions: Drug: Pentoxifylline; Other: placebo distilled water

• Registration Number: NCT07088328
• Lead Sponsor: Alexandria University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-19
• Study First Submitted QC: 2025-07-19
• Last Update Submitted: 2025-07-19
• Study First Posted: 2025-07-28
• Last Update Posted: 2025-07-28
• Study Start: 2025-07-30
• Primary Completion: 2026-01-30
• Study Completion: 2026-03-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pentoxifylline group	Pentoxifylline	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 distilled water	They will not be given pentoxifylline as reno-protective drug

Primary Outcome Measures

Name	Time	Method
Renal function	daily in the first 3 days of life.	creatinine level in mg/dl.

Secondary Outcome Measures

Name	Time	Method
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