2. Group 2: Comparison group (Universal antibiotic group) primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Project staff, nurses and resident doctors looking after the neonate will not be blinded. The assessment of the primary outcome will be performed by a blinded adjudicator, who is not involved in the recruitment and monitoring of subjects. A part of the case report form (CRF) containing relevant details of all episodes of sickness in the 1st week of life will be detached from the main form and will be sent to the blinded adjudicator. This part will be linked to the main form only by a unique identification number. No patient identifiers or allocation group will be mentioned on the part sent to the blinded adjudicator. whoMasked: OUTCOMES_ASSESSOR count: 1500 type: ESTIMATED name: Antibiotics measure: Composite of all-cause mortality and/or any episode of culture-positive sepsis and/or severe sepsis* within the 1st 7 days after randomization measure: Need for intravenous antibiotics for ≥ 48 hours within the 1st 7 days after randomization measure: All-cause Mortality within 1st 7 days after randomization measure: Blood culture-positive sepsis of any severity within 1st 7 days after randomization measure: Episode of severe sepsis within 1st 7 days after randomization measure: Composite of mortality/blood culture positive sepsis/severe sepsis within 1st 72 hours after randomization measure: Individual components of composite outcome within 1st 72 hours after randomization measure: Composite of mortality/blood culture positive sepsis/severe sepsis during hospital stay measure: Individual components of composite outcome during hospital stay measure: Necrotizing enterocolitis, stage II-III by modified Bell's staging criteria during hospital stay measure: Composite of mortality/blood culture positive sepsis/severe sepsis during 1st 30 days after randomization measure: Individual components of composite outcome during 1st 30 days measure: Necrotizing enterocolitis, stage II-III by modified Bell's staging criteria measure: Sepsis-related mortality within 1st 72 hours after randomization measure: Sepsis-related mortality within 7 day after randomization measure: Sepsis-related mortality during hospital stay after randomization measure: Sepsis-related mortality during 1st 30 days after randomization measure: Clinical sepsis within 1st 72 hours after randomization measure: Clinical sepsis within 7 days after randomization measure: Clinical sepsis during hospital stay measure: Clinical sepsis within 1st 30 days after randomization measure: Episode of Probable EONS within 72 hours after randomization measure: Episode of Probable EONS within 7 days after randomization measure: Episode of asymptomatic proven EONS within 72 hours after randomization measure: Need for sepsis workup during 1st 72 hours after randomization measure: Need for sepsis workup during 1st 7 days after randomization measure: Need for sepsis workup during 1st 30 days after randomization measure: Need for sepsis workup during hospital stay measure: Cumulative duration of antibiotic therapy during 1st 7 days after randomization measure: Cumulative duration of antibiotic therapy during 1st 72 hrs after randomization measure: Cumulative duration of antibiotic therapy during hospital stay measure: Duration of hospitalization measure: Episodes of healthcare associated infection during hospital stay. measure: Adverse effects until day 30 after randomization measure: Serious adverse effects until day 30 after randomization sex: ALL minimumAge: 0 Hours maximumAge: 4 Hours stdAges: CHILD facility: Post Graduate Institute of Medical Education and Research (PGIMER) city: Chandigarh zip: 160012 country: India lat: 30.73629 lon: 76.7884 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-04-02 uploadDate: 2024-04-02T01:02 filename: Prot_SAP_000.pdf size: 213987 hasResults: False