About this trial
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").
Eligibility criteria
Qualifiers
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]
Disqualifiers
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
Trial design
Treatments tested in this trial
- Antibiotics
Treatment groups
Sponsors and collaborators
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