Nephroprotection Following Perinatal Asphyxia: Randomized Controlled Trial

NCT ID: NCT07088328

Last Updated: 2025-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-30

Study Completion Date

2026-03-02

Brief Summary

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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

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Conditions

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Hypoxic-Ischemic Encephalopathy Neonatal Encephalopathy Pentoxifylline Adverse Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Pentoxifylline group

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

Group Type ACTIVE_COMPARATOR

Pentoxifylline

Intervention Type DRUG

Intravenous administration for 3 days

Control group

They will not be given pentoxifylline as reno-protective drug

Group Type PLACEBO_COMPARATOR

placebo distilled water

Intervention Type OTHER

Intravenous administration for 3 days

Interventions

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Pentoxifylline

Intravenous administration for 3 days

Intervention Type DRUG

placebo distilled water

Intravenous administration for 3 days

Intervention Type OTHER

Eligibility Criteria

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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).

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Minimum Eligible Age

1 Hour

Maximum Eligible Age

5 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Marwa Mohamed Farag

Assistant professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Marwa M Farag, PhD

Role: CONTACT

01288681788

Other Identifiers

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0108348

Identifier Type: -

Identifier Source: org_study_id

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