Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in India / NCT06377397
Recruiting Phase 3

Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates

NCT06377397 · tracked via the Priya Life Science India tracker
Sponsor
Indian Council of Medical Research
Phase
Phase 3
Started
2025-06-07
Last updated
2026-10-27

Condition(s) studied

SepsisPROM, Preterm (Pregnancy)Early-Onset Neonatal SepsisPreterm Premature Rupture of MembranePreterm Birth

Investigational drug(s) / intervention(s)

Antibiotics

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.

Study 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").

Eligibility

Sex
ALL
Min age
4 Hours
Max age
4 Hours
Healthy volunteers
No
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. \-

Primary outcome measure(s)

  • 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
    Either mortality due to any cause and/or an episode of culture-positive sepsis and/or severe sepsis. These outcomes will be measured within the 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
    Composite outcome of mortality due to any cause within the 1st 7 days after randomisation and/or requirement for intravenous antibiotic courses whose cumulative duration is \> 48 hours within the first 7 days after randomization

Trial sites (9)

FacilityCityRegionStatus
Government medical College Chandigarh Chandigarh Chandigarh Recruiting
Post Graduate Institute of Medical Education and Research (PGIMER) Chandigarh Chandigarh Recruiting
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences Rohtak Haryana Recruiting
IGICH bengaluru Bengaluru Karnataka Recruiting
Government Medical College, Aurangabad Chhatrapati Sambhajinagar Maharashtra Recruiting
King Edward Memorial Hospital Mumbai Maharashtra Recruiting
Lady Hardinge Medical College and Kalawati Saran Children's Hospital New Delhi New Delhi Recruiting
IOG Chennai Chennai Tamil Nadu Recruiting
KGMU Lucknow Lucknow Uttar Pradesh Recruiting

More Indian Council of Medical Research trials in India

Intensified Short Course Regimen for TBM in Adults Starting soon
Development, Validation and Evaluation of a Deprescribing Tool Recruiting

Other trials for the same condition

Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06377397 on ClinicalTrials.gov ↗ ← All trials in India