Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates

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").

NCT Number	NCT06377397
Lead Sponsor	Indian Council of Medical Research Collaborators: Lady Hardinge Medical College, King George's Medical University, Indira Gandhi Institute of Child Health, Institute of Obstetrics and Gynecology, Government Medical College, Chandigarh, Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak, Government Medical College, Aurangabad, King Edward Memorial Hospital, Mumbai
Conditions	Sepsis, PROM, Preterm (Pregnancy), Early-Onset Neonatal Sepsis, Preterm Premature Rupture of Membrane, Preterm Birth
Enrollment	1,500 participants
Start Date	2024-04-15
Primary Completion	2027-04-15 (estimated)
Study Completion	2028-04-14 (estimated)
Updated on ClinicalTrials.gov	2024-04-22