Efficacy And Safety Of Short Course Antibiotic Therapy (72hrs) As Compared To Standard Duration (5-7 Days) Of Therapy In Preterm Neonates With Culture Negative Early Onset Sepsis: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Early-Onset Neonatal Sepsis
- Sponsor
- Lady Hardinge Medical College
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Incidence of 'Treatment Failure'
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Sushma Nangia, M.D.
Director Professor & Head, Department of Neonatology
Lady Hardinge Medical College
Eligibility Criteria
Inclusion Criteria
- Not provided
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
Outcomes
Primary Outcomes
Incidence of 'Treatment Failure'
Time Frame: 15 days of stopping antibiotics
New onset appearance of clinical signs and symptoms requiring initiation of antibiotics
Secondary Outcomes
- Mortality(Till 1 month of life)
- Need for additional courses of antibiotic therapy(Till 1 month of life)
- Length of hospital stay(From date of birth until date of death or discharge whichever come assessed till 1 month of life)