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
Phase 3
- Conditions
- Hypoxic Ischemic encephalopathy.Hypoxic ischemic encephalopathy [HIE], unspecifiedP91.60
- Registration Number
- IRCT20110807007244N10
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 124
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
Congenital malformations
maternal chorioamnionitis
Intrauterine growth retardation
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method 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.