Efficacy And Safety Of Short Course Antibiotic Therapy In Preterm Neonates With Early Onset Sepsis (NCT06197269) | Clinical Trial Compass
CompletedNot Applicable
Efficacy And Safety Of Short Course Antibiotic Therapy In Preterm Neonates With Early Onset Sepsis
India75 participantsStarted 2022-04-15
Plain-language 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.
Who can participate
Age range28 Weeks – 36 Weeks
SexALL
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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