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").
Gestational age of 26 to 34 weeks
Chronological age 4 hours
Prolonged rupture of membranes >18 hours
Pre-labour rupture of membranes [as all subjects will be preterm, this is effectively pPROM]
Life-threatening congenital malformation
Severe perinatal asphyxia (Apgar score <5 at 10 minutes or cord pH <7.0)
Clinical chorioamnionitis# [see definition below]
Foul-smelling liquor
Parallel
Antibiotics
DrugIn 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 enrollment even if they do not have any clinical signs of sepsis at enrollment
Composite of all-cause mortality and/or any episode of culture-positive sepsis and/or severe sepsis* within the 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", which for all practical purposes, is equivalent to the "1st 7 days of life" since participants will be randomized at about 4 hours of life. Hence, the duration expressed after randomization and of life will be used interchangeably for this outcome and other outcomes.
Need for intravenous antibiotics for ≥ 48 hours within the 1st 7 days after randomization
Requirement for intravenous antibiotic courses whose duration is ≥ 48 hours with the onset of the course within the first 7 days after randomization. For all practical purposes, this would be equivalent to the 1st 7 days of life since participants will be randomized at about 4 hours of life.
All-cause Mortality within 1st 7 days after randomization
Mortality due to any cause
Blood culture-positive sepsis of any severity within 1st 7 days after randomization
Blood culture proven septicemia
Episode of severe sepsis within 1st 7 days after randomization
Any episode of severe sepsis during 1st 7 days after randomization. Severe sepsis be defined as clinical signs of sepsis AND either a positive blood culture or laboratory evidence of sepsis (either CRP OR Procalcitonin above the age-appropriate cut-off value OR any two of the CBC parameters outside the age-appropriate ranges OR chest x-ray suggestive of pneumonia) AND one or more of the following indices of severity \[Need for intubation and mechanical ventilation, Need for inotropes \>10 mic/kg/min dopamine or \>10 mic/kg/min dobutamine or adrenaline \> 0.05 mic/kg/min, Need for exchange transfusion, Need for platelet concentrates or FFP, Meningitis (defined as either CSF culture positive or Gram stain positive or Cell count \>25/microlitre or glucose \<25 mg/dl or protein \>180 mg/dl)\]
Composite of mortality/blood culture positive sepsis/severe sepsis within 1st 72 hours after randomization
Either mortality and/or blood culture-positive sepsis and/or severe sepsis
Click on the lead sponsor to view all of their trials.
Indian Council of Medical Research
Lead sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Sponsor institution
Lady Hardinge Medical College
Collaborator
King George's Medical University
Collaborator
Indira Gandhi Institute of Child Health
Collaborator
Institute of Obstetrics and Gynecology
Collaborator
Government Medical College, Chandigarh
Collaborator
Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak
Collaborator
Government Medical College, Aurangabad
Collaborator
King Edward Memorial Hospital, Mumbai
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
