Status:
COMPLETED
Efficacy And Safety Of Short Course Antibiotic Therapy In Preterm Neonates With Early Onset Sepsis
Lead Sponsor:
Lady Hardinge Medical College
Conditions:
Early-Onset Neonatal Sepsis
Antibiotic Stewardship
Eligibility:
All Genders
28-36 years
Phase:
NA
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...
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: Antibi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 14 2024
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06197269
Start Date
April 15 2022
End Date
April 14 2024
Last Update
August 13 2024
Active Locations (1)
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1
Lady Hardinge Medical college
New Delhi, National Capital Territory of Delhi, India, 110001