early onset neonatal sepsis. Bacterial sepsis of newborn, unspecified
Conditions
Interventions
Intervention 1: Intervention group: will be treated for three days with empirical intravenous antibiotic (ampicillin + aminoglycoside, dosage based on weight) Ampicillin for infants with weight 2 Kg,
Treatment - Drugs
Intervention group: will be treated for three days with empirical intravenous antibiotic (ampicillin + aminoglycoside, dosage based on weight) Ampicillin for infants with weight 2 Kg, 50mg/kg/8hr.
Am
Control group:will be treated for five days with empirical intravenous antibiotic (ampicillin + aminoglycoside, dosage based on weight) Ampicillin for infants with weight 2 Kg, 50mg/kg/8hr. Amikacin f
Sponsors
Babol University Of Medical Sciences
Eligibility
Sex/Gender
All
Age
No minimum to 1 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Infants with birth weight over 1500 g; and/or gestational age over 34 weeks; within 7 days postnatal age; with clinical symptoms of neonatal sepsis (fever, respiratory distress, poor feeding, vomiting,lethargy, apnea, seizure, etc); and/or have abnormal CBC, diff, CRP,ESR tests; and/or CXR.They receive empirical intravenous antibiotic treatment until determination of the results of blood cultures and they include If the results of blood culture is negative and symptoms of neonatal sepsis resolve. Exclusion criteria: Infants with birth weight under 1500 g; and/or gestational age less than 34 weeks; infants older than 7 days; no improvement of clinical symptoms (fever, respiratory distress, poor feeding, vomiting,lethargy, apnea, seizure, etc) after 72 hours of antibiotic therapy; CRP levels remain abnormal despite treatment; infants with major congenital malformations; severe perinatal asphyxia (defined as Apgar score<3 at 5 minutes); clinically suspected bone or joint infection; those undergoing surgery; parental unwillingness to enter the research project.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| C-reactive protein. Timepoint: At the end of three or five-day course of treatment. Method of measurement: Quantitative measurement of serum CRP.;History and Physical examination. Timepoint: Two days and fifteen days after discharge. Method of measurement: visited by attending physician for history and symptoms of neonatal sepsis. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactReza Behmadi
Non-Communicable Pediatric Diseases Center
Outcome results
None listed