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RECRUITING

NCT06377397

PHASE3

Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates

Sponsor: Indian Council of Medical Research

View on ClinicalTrials.gov

Summary

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 soon after birth (as above) require fewer antibiotic courses cumulatively of more than 48 hours duration in the 1st week of life. 3. To find out whether infants receiving selective antibiotics (as above) compared to those receiving antibiotics from soon after birth (as above) are significantly different with respect to a wide range of secondary outcomes (listed under "Outcomes").

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

Key Details

Gender

All

Age Range

4 Hours - 4 Hours

Study Type

INTERVENTIONAL

Enrollment

1500

Start Date

2025-06-07

Completion Date

2028-05

Last Updated

2026-10-27

Healthy Volunteers

Conditions

Sepsis PROM, Preterm (Pregnancy)Early-Onset Neonatal Sepsis Preterm Premature Rupture of Membrane Preterm Birth

Interventions

DRUG

Antibiotics

In experimental arm, intravenous antibiotics as per the written down empirical antibody policy of the unit will be administered selectively to those newborn infants who later develop clinical signs of sepsis according to a predefined repertory of clinical signs. In active comparator arm, intravenous antibiotics as per the written down empirical antibody policy of the unit will be administered pre-emptively to all newborn infants from randomization even if they do not have any clinical signs of sepsis at randomization.

Inclusion criteria: * Gestational age of 26 0/7 to 34 6/7 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 4 hours OR need for CPAP less than or equal to 6 cms and FiO2 less than or equal to 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. \-

Locations (9)

Government medical College Chandigarh

Chandigarh, Chandigarh, India

Post Graduate Institute of Medical Education and Research (PGIMER)

Chandigarh, Chandigarh, India

Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences

Rohtak, Haryana, India

IGICH bengaluru

Bengaluru, Karnataka, India

Government Medical College, Aurangabad

Aurangabad, Maharashtra, India

King Edward Memorial Hospital

Mumbai, Maharashtra, India

Lady Hardinge Medical College and Kalawati Saran Children's Hospital

New Delhi, New Delhi, India

IOG Chennai

Chennai, Tamil Nadu, India

KGMU Lucknow

Lucknow, Uttar Pradesh, India