Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates At-risk of Early-onset Bacterial Sepsis: a Multicentric, Randomized, Controlled, Non-inferiority Trial (the SAUNA Trial)

IIRPIG-2023-0000070

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").

2024-04-15

2027-04-15

2028-04-14

Not yet recruiting

Early phase I

1500

Inclusion criteria: * Gestational age of 26 to 34 weeks * Chronological age 4 hours * Have any one or both of the following risk factors of EONS: * Prolonged rupture of membranes \>18 hours * Pre-labour rupture of membranes \[as all subjects will be preterm, this is effectively pPROM\] * Are either asymptomatic or have no signs attributable to sepsis at 4 hours. This will be defined as absence of the following clinical signs or need for interventions mentioned below: 1. Apnea (Standard definition) requiring intervention at any time until enrolment. 2. Need for a fluid bolus or inotropic support at any time until enrolment. 3. Seizures or seizure-like activity at any time until enrolment. 4. Upper GI bleed in the absence of a history of ante-partum hemorrhage at any time until enrolment. 5. Pus from any site at any time until enrolment. 6. Need for CPAP \>6 cms of water with FiO2 \>35% at 6-8 hours OR need for CPAP £6 cms and FiO2 £35% but with increasing requirement of support\*\* 7. Chest Xray (if performed) with radiological features of pneumonia. 8. Need for intubation and mechanical ventilation. 9. Temperature \>37.5°C or \<36°C, unexplained by environmental causes 10. Feed intolerance \[bilious or bloodstained vomiting (or gastric residuals) or visibly distended abdomen or \>50% of the previous feed volume as gastric residuals\] 11. Lethargy or unarousability 12. Sclerema Exclusion Criteria: Subjects will be excluded if they have any 1 of the following: <!-- --> 1. Life-threatening congenital malformation 2. Severe perinatal asphyxia (Apgar score \<5 at 10 minutes or cord pH \<7.0) 3. Clinical chorioamnionitis# \[see definition below\] 4. Foul-smelling liquor 5. Multiple gestation 6. Received a dose of antibiotics 7. Positive amniotic fluid culture (if performed and available prior to randomization) 8. Treating neonatologist unwilling to enroll the patient in the trial on the grounds that the patient needs antibiotics. -

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Neonates will be randomized to 1 of the following groups:\n\n1. Group 1: Intervention group (Selective antibiotic group)\n2. 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'}}

2024-04-22