Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age0-4
SponsorIndian Council of Medical Research

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

1,500 Participants
are divided into 2 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