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NCT06377397
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Conditions: Sepsis, PROM, Preterm (Pregnancy), Early-Onset Neonatal Sepsis, Preterm Premature Rupture of Membrane, Preterm Birth
Sex: All
Ages: 4 Hours – 4 Hours
Healthy volunteers: No
Phase: PHASE3
Enrollment: 1500
Sponsor: Indian Council of Medical Research
Location: Government medical College Chandigarh Chandigarh Chandigarh
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 Criteria
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 \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 \
Source: ClinicalTrials.gov (NCT06377397). StuddyBuddy aggregates publicly available trial information.