Health Condition 1: P369- Bacterial sepsis of newborn, unspecified Health Condition 2: null- Neonates of gestational age more than or equal to 34 weeks with birth weight above 1800 g who are asymptomatic at birth and can be fed orally.
Conditions
Interventions
Intervention1: Inj. ampicillin plus amikacin: Inj. ampicillin will be administered at a dose of 100 mg/kg/day in two divided doses for 3 days.
Inj. amikacin will be administered at a dose of 15 mg/kg/
Sponsors
Nil
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: include all the following: 1. Consecutively delivered neonates of gestational age 34 weeks and beyond 2. with maternal risk factors for sepsis 2. who are otherwise asymptomatic at birth 3. accepting cup feeds and/or breastfeeds Maternal risk factors for sepsis are defined as presence of one or more of the following: o Leaking per vagina >18 hours o Foul smelling liquor o Maternal intrapartum fever >37.5°C in the period from onset of labor to 1 hour after delivery. Exclusion criteria: 1. Perinatal asphyxia 2. Respiratory distress 3. Major congenital malformations
Exclusion criteria
Exclusion criteria: 1. Perinatal asphyxia 2. Meconium aspiration syndrome 3. Congenital infections (TORCH, syphilis and HIV) 4. Surgical conditions and major congenital anomalies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Development of clinical signs of sepsis not explained otherwise with or without a positive blood cultureTimepoint: 72 hours of age | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Development of sepsis with or without a positive blood culture by 7 days of life 2. Feasibility 3. Adherence to study protocol 4. Adverse effects of drug therapy 5. Cost-effectiveness Timepoint: 72 hours and 7 days of life | — |
Countries
India
Contacts
Public ContactAshok Kumar
Institute of Medical Sciences Banaras Hindu University
Outcome results
None listed