Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates (NCT06377397) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
India1,500 participantsStarted 2024-04-15
Plain-language 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 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").
Who can participate
Age range0 Hours – 4 Hours
SexALL
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Inclusion criteria
✓. Apnea (Standard definition) requiring intervention at any time until enrolment.
✓. Need for a fluid bolus or inotropic support at any time until enrolment.
✓. Seizures or seizure-like activity at any time until enrolment.
✓. Upper GI bleed in the absence of a history of ante-partum hemorrhage at any time until enrolment.
✓. Pus from any site at any time until enrolment.
✓. Need for CPAP \>6 cms of water with FiO2 \>35% at 6-8 hours OR need for CPAP £6 cms and FiO2 £35% but with increasing requirement of support\*\*
✓. Chest Xray (if performed) with radiological features of pneumonia.
✓. Need for intubation and mechanical ventilation.
Exclusion criteria
✕. Life-threatening congenital malformation
✕. Severe perinatal asphyxia (Apgar score \<5 at 10 minutes or cord pH \<7.0)
What they're measuring
1
Composite of all-cause mortality and/or any episode of culture-positive sepsis and/or severe sepsis* within the 1st 7 days after randomization
Timeframe: Within 1st 7 days after randomization
2
Need for intravenous antibiotics for ≥ 48 hours within the 1st 7 days after randomization