Nephroprotection Following Perinatal Asphyxia: Randomized Controlled Trial

Alexandria University

Status: Not yet enrolling

Conditions: Neonatal Encephalopathy; Hypoxic-Ischemic Encephalopathy; Pentoxifylline Adverse Reaction

Treatments: Other: placebo distilled water; Drug: Pentoxifylline

Study type: Interventional

Funder types: Other

Identifiers

NCT07088328

0108348

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 1 hour to 5 days old

Volunteers: No 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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups, including a placebo group

Pentoxifylline group

Active Comparator group

Description:

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

Treatment:

Drug: Pentoxifylline

Control group

Placebo Comparator group

Description:

They will not be given pentoxifylline as reno-protective drug

Treatment:

Other: placebo distilled water