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NCT Number: NCT07088328

Nephroprotection Following Perinatal Asphyxia: Randomized Controlled 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.

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Key information

Conditions

Hypoxic-Ischemic Encephalopathy Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Neonatal Encephalopathy Nervous System Diseases Pathological Conditions, Signs and Symptoms Pentoxifylline Adverse Reaction Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

1 hour–5 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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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Treatment and study plan

Pentoxifylline

Drug

Intravenous administration for 3 days

placebo distilled water

Other

Intravenous administration for 3 days

Primary outcomes

  1. Renal function

    Time frame: daily in the first 3 days of life.

    creatinine level in mg/dl.

Secondary outcomes

  1. Renal Doppler sonography

    Time frame: first 3 days of life

    Peak systolic velocity (PSV) in cm/sec End diastolic velocity (EDV) in cm/sec.

  2. cystatin C

    Time frame: first 24 hours of life

    measure level using ng/L

Study contacts

Contact information is provided by the study sponsor or research team.

Marwa M Farag, PhD

CONTACT

[email protected]

01288681788

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2025
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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