Antibiotic Stewardship, Early-Onset Neonatal Sepsis
Conditions
Brief summary
Objective of the study is to compare the efficacy and safety of 'Short duration antibiotic' (72hrs) and 'Standard duration antibiotic'(5 - 7days) in preterm neonates ( \>28weeks and \>1000grams ) with culture negative early onset sepsis.
Detailed description
Enrolled participants will be randomly allocated to one of two study groups: 1) Short duration antibiotic' (72hrs), 2) Standard duration antibiotic'(5 - 7days) Short duration antibiotic group: Antibiotic therapy stopped at the time of randomization i.e. 72 hours after starting antibiotics Standard duration antibiotic group: antibiotics therapy continued for 5-7 days further after 72 hrs of starting antibiotics.
Interventions
OTHERShort duration antibiotics
antibiotic therapy will be stopped at the time of randomization i.e. 72 hrs after starting treatment
OTHERStandard duration antibiotics
Antibiotics will be continued for 5-7 days more, 72 hrs after starting treatment.
Sponsors
Lady Hardinge Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
28 Weeks to 36 Weeks
Healthy volunteers
No
Inclusion criteria
(All must be present) * All Preterm neonates (Gestational age \>28weeks and \>1000grams) * age less than 72hours of life * Started on antibiotic therapy based on presence of symptoms attributable to sepsis and /or positive sepsis screen but sterile blood culture * Symptoms resolved at time of randomization
Exclusion criteria
* Antibiotics started based on risk factors * Infants with major congenital anomalies or syndromes. * Presence of site specific infections including meningitis, pneumonia * Neonates suspected to have inborn errors of metabolism * Neonates with Severe birth asphyxia, (Apgar score at 5min \<4 and cord Ph\< 7.0,base excess \<-16) * Neonates underwent major surgery in 1st week of life * Deemed by Doctor in charge to be sick enough to be continued on antibiotics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of 'Treatment Failure' | 15 days of stopping antibiotics | New onset appearance of clinical signs and symptoms requiring initiation of antibiotics |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | Till 1 month of life | Death due to any reason |
| Need for additional courses of antibiotic therapy | Till 1 month of life | Additional courses during the study time frame |
| Length of hospital stay | From date of birth until date of death or discharge whichever come assessed till 1 month of life | Duration of hospital stay |
Countries
India
Outcome results
None listed