Nephroprotection Following Perinatal Asphyxia: Randomized Controlled Trial

NCT07088328 | Not Yet Recruiting

• 1 other identifier: 0108348
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypoxic-Ischemic Encephalopathy; Neonatal Encephalopathy; Pentoxifylline Adverse Reaction

Keywords

preterm infants; nephroprotection

Outcome Measures

Primary Outcomes (1)

• Renal function

  creatinine level in mg/dl.

  daily in the first 3 days of life.

Secondary Outcomes (2)

• Renal Doppler sonography

  first 3 days of life

• cystatin C

  first 24 hours of life

Study Arms (2)

Pentoxifylline group

ACTIVE COMPARATOR

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

Drug: Pentoxifylline

Control group

PLACEBO COMPARATOR

They will not be given pentoxifylline as reno-protective drug

Other: placebo distilled water

Interventions

Pentoxifylline DRUG

Intravenous administration for 3 days

Pentoxifylline group

placebo distilled water OTHER

Intravenous administration for 3 days

Control group

Eligibility Criteria

• Age: 1 Hour - 5 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Neonates with any of the following will be excluded:
• \. 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).

Sponsors & Collaborators

• Alexandria University: lead

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Marwa M Farag, PhD

CONTACT

01288681788; d.marwa.farag@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Pediatrics

Study Record Dates

• First Submitted: July 19, 2025
• First Posted: July 28, 2025
• Study Start: July 30, 2025
• Primary Completion: January 30, 2026
• Study Completion: March 2, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-07