Comparison of the effects of topiramate and azithromycin on the balance of antioxidants, interleukin 6, 8 and 1 in infants with cerebral complications of birth asphyxia

Comparison of the effect of azithromycin and topiramate on prooxidant antioxidant balance, interleukin 6, 8 and 1 in infants with hypoxic-ischemic encephalopathy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20110807007244N10

Enrollment

124

Registered

2023-09-19

Start date

2024-02-20

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxic Ischemic encephalopathy. Hypoxic ischemic encephalopathy [HIE], unspecified

Interventions

Intervention 1: Intervention group: infants suffered from hypoxic ischemic encephalopathy who receive azithromycin ( 20 mg/kg/day, orally for 3 days and then 10 mg/kg/day, orally for 2 ) and/or Topira

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: History of identifiable birth events (placenta separation, uterine rupture, umbilical cord prolapse) along with birth monitoring disorders Umbilical cord pH less than 7 or less than 7.2 in the blood sample in the first hour of birth BE<-12 in umbilical cord blood sample in the first hour of birth The need for positive pressure ventilation for more than one minute in the delivery room

Exclusion criteria

Exclusion criteria: Congenital malformations maternal chorioamnionitis Intrauterine growth retardation

Design outcomes

Primary

Measure	Time frame
Pro oxidant antioxidant balance. Timepoint: The beginning of the study. Method of measurement: Pro-Oxidant Antioxidant Balance (PAB) assay.;Interleukin 6. Timepoint: The beginning of the study. Method of measurement: Enzyme-linked immunosorbent assay.;Interleukin 8. Timepoint: The beginning of the study. Method of measurement: Enzyme-linked immunosorbent assay.;Interleukin 1 B. Timepoint: The beginning of the study. Method of measurement: Enzyme-linked immunosorbent assay.	—

Measure

Time frame

Pro oxidant antioxidant balance. Timepoint: The beginning of the study. Method of measurement: Pro-Oxidant Antioxidant Balance (PAB) assay.;Interleukin 6. Timepoint: The beginning of the study. Method of measurement: Enzyme-linked immunosorbent assay.;Interleukin 8. Timepoint: The beginning of the study. Method of measurement: Enzyme-linked immunosorbent assay.;Interleukin 1 B. Timepoint: The beginning of the study. Method of measurement: Enzyme-linked immunosorbent assay.

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Secondary

Measure	Time frame
Pro-Oxidant Antioxidant Balance. Timepoint: Three days after birth. Method of measurement: Pro-Oxidant Antioxidant Balance assay.;Interleukin 6. Timepoint: Three days after birth. Method of measurement: Enzyme-linked immunosorbent assay.;Interleukin 8. Timepoint: Three days after birth. Method of measurement: Enzyme-linked immunosorbent assay.;Interleukin 1B. Timepoint: Three days after birth. Method of measurement: Enzyme-linked immunosorbent assay.	—

Measure

Time frame

Pro-Oxidant Antioxidant Balance. Timepoint: Three days after birth. Method of measurement: Pro-Oxidant Antioxidant Balance assay.;Interleukin 6. Timepoint: Three days after birth. Method of measurement: Enzyme-linked immunosorbent assay.;Interleukin 8. Timepoint: Three days after birth. Method of measurement: Enzyme-linked immunosorbent assay.;Interleukin 1B. Timepoint: Three days after birth. Method of measurement: Enzyme-linked immunosorbent assay.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactHassan Boskabadi

Mashhad University of Medical Sciences

Boskabadih@mums.ac.ir+98 51 3841 2069

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026