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Life sciences · Phase 3 Trial
ClinicalTrials.gov · October 27, 2026
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Phase 3 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT06377397). This is a study registration, not published results. Lead sponsor: Indian Council of Medical Research. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 1500 participants (ESTIMATED). Conditions: Sepsis, PROM, Preterm (Pregnancy), Early-Onset Neonatal Sepsis, Preterm Premature Rupture of Membrane, Preterm Birth. Interventions: DRUG: Antibiotics. Primary outcome measures: Composite of all-cause mortality and/or any episode of culture-positive sepsis and/or severe sepsis within the 1st 7 days after randomization , Within 1st 7 days after randomization; All-cause mortality within 7 days (i.e. 168 hours) after randomization, or cumulative intravenous antibiotic exposure exceeding 48 hours during those same 168 hours, summed across all antibiotic courses , Within 1st 7 days after randomization. Brief 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").