Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-24 @ 10:51 PM
NCT ID:
NCT06197269
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
28 Weeks
Maximum Age:
36 Weeks
Study:
NCT06197269
Study Brief:
Protocol Section:
NCT06197269