protocolSection identificationModule nctId: NCT06377397, orgStudyIdInfo id: IIRPIG-2023-0000070, briefTitle: Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates, acronym: SAUNA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2027-04-15, completionDateStruct date: 2028-04-14, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Indian Council of Medical Research, class: OTHER_GOV, collaborators name: Lady Hardinge Medical College, collaborators name: King George's Medical University, collaborators name: Indira Gandhi Institute of Child Health, collaborators name: Institute of Obstetrics and Gynecology, collaborators name: Government Medical College, Chandigarh, collaborators name: Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak, collaborators name: Government Medical College, Aurangabad, collaborators name: King Edward Memorial Hospital, Mumbai, descriptionModule briefSummary: Preterm infants are born at less than 37 weeks of pregnancy. Sometimes a break or tear in the fluid filled bag that surrounds and protects the infant during pregnancy leads to an untimely birth. This state puts the infant at risk of serious condition called sepsis. Sepsis is a condition in which body responds inappropriately to an infection. Sepsis may progress to septic shock which can result in the loss of life. Doctors give antibiotics to treat sepsis.The goal of this research study is to find out:1. Among neonates at risk of early-onset neonatal sepsis, whether a policy of administering antibiotics selectively to a subset of at-risk infants who later develop signs of sepsis is not inferior to administering antibiotics to all at-risk infants in the 1st week of life.2. To find out if infants receiving selective antibiotics (as above) compared to those receiving antibiotics from birth (as above) require fewer antibiotic courses of 48 hours duration or more in the 1st week of life.3. To find out whether infants receiving selective antibiotics (as above) compared to those receiving antibiotics from birth (as above) are significantly different with respect to a wide range of secondary outcomes (listed under "Outcomes")., conditionsModule conditions: Sepsis, conditions: PROM, Preterm (Pregnancy), conditions: Early-Onset Neonatal Sepsis, conditions: Preterm Premature Rupture of Membrane, conditions: Preterm Birth, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Neonates will be randomized to 1 of the following groups:1. Group 1: Intervention group (Selective antibiotic group)2. Group 2: Comparison group (Universal antibiotic group), primaryPurpose: TREATMENT, maskingInfo 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, enrollmentInfo count: 1500, type: ESTIMATED, armsInterventionsModule interventions name: Antibiotics, outcomesModule primaryOutcomes 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, primaryOutcomes measure: Need for intravenous antibiotics for ≥ 48 hours within the 1st 7 days after randomization, secondaryOutcomes measure: All-cause Mortality within 1st 7 days after randomization, secondaryOutcomes measure: Blood culture-positive sepsis of any severity within 1st 7 days after randomization, secondaryOutcomes measure: Episode of severe sepsis within 1st 7 days after randomization, secondaryOutcomes measure: Composite of mortality/blood culture positive sepsis/severe sepsis within 1st 72 hours after randomization, secondaryOutcomes measure: Individual components of composite outcome within 1st 72 hours after randomization, secondaryOutcomes measure: Composite of mortality/blood culture positive sepsis/severe sepsis during hospital stay, secondaryOutcomes measure: Individual components of composite outcome during hospital stay, secondaryOutcomes measure: Necrotizing enterocolitis, stage II-III by modified Bell's staging criteria during hospital stay, secondaryOutcomes measure: Composite of mortality/blood culture positive sepsis/severe sepsis during 1st 30 days after randomization, secondaryOutcomes measure: Individual components of composite outcome during 1st 30 days, secondaryOutcomes measure: Necrotizing enterocolitis, stage II-III by modified Bell's staging criteria, secondaryOutcomes measure: Sepsis-related mortality within 1st 72 hours after randomization, secondaryOutcomes measure: Sepsis-related mortality within 7 day after randomization, secondaryOutcomes measure: Sepsis-related mortality during hospital stay after randomization, secondaryOutcomes measure: Sepsis-related mortality during 1st 30 days after randomization, secondaryOutcomes measure: Clinical sepsis within 1st 72 hours after randomization, secondaryOutcomes measure: Clinical sepsis within 7 days after randomization, secondaryOutcomes measure: Clinical sepsis during hospital stay, secondaryOutcomes measure: Clinical sepsis within 1st 30 days after randomization, secondaryOutcomes measure: Episode of Probable EONS within 72 hours after randomization, secondaryOutcomes measure: Episode of Probable EONS within 7 days after randomization, secondaryOutcomes measure: Episode of asymptomatic proven EONS within 72 hours after randomization, secondaryOutcomes measure: Need for sepsis workup during 1st 72 hours after randomization, secondaryOutcomes measure: Need for sepsis workup during 1st 7 days after randomization, secondaryOutcomes measure: Need for sepsis workup during 1st 30 days after randomization, secondaryOutcomes measure: Need for sepsis workup during hospital stay, secondaryOutcomes measure: Cumulative duration of antibiotic therapy during 1st 7 days after randomization, secondaryOutcomes measure: Cumulative duration of antibiotic therapy during 1st 72 hrs after randomization, secondaryOutcomes measure: Cumulative duration of antibiotic therapy during hospital stay, secondaryOutcomes measure: Duration of hospitalization, secondaryOutcomes measure: Episodes of healthcare associated infection during hospital stay., secondaryOutcomes measure: Adverse effects until day 30 after randomization, secondaryOutcomes measure: Serious adverse effects until day 30 after randomization, eligibilityModule sex: ALL, minimumAge: 0 Hours, maximumAge: 4 Hours, stdAges: CHILD, contactsLocationsModule locations facility: Post Graduate Institute of Medical Education and Research (PGIMER), city: Chandigarh, zip: 160012, country: India, geoPoint lat: 30.73629, lon: 76.7884, documentSection largeDocumentModule largeDocs 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