Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates

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").

Conditions

• Sepsis
• PROM, Preterm (Pregnancy)
• Early-Onset Neonatal Sepsis
• Preterm Premature Rupture of Membrane
• Preterm Birth

Interventions

DRUG

Antibiotics

In 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

Sponsors & Collaborators

• Lady Hardinge Medical College

  collaborator OTHER_GOV

• King George's Medical University

  collaborator OTHER

• Indira Gandhi Institute of Child Health

  collaborator UNKNOWN

• Institute of Obstetrics and Gynecology

  collaborator UNKNOWN

• Government Medical College, Chandigarh

  collaborator OTHER

• Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak

  collaborator OTHER

• Government Medical College, Aurangabad

  collaborator OTHER_GOV

• King Edward Memorial Hospital, Mumbai

  collaborator OTHER_GOV

• Indian Council of Medical Research

  lead OTHER_GOV

Principal Investigators

• Sourabh Dutta, MD, Ph.D · Post Graduate Institute of Medical Education and Research, Chandigarh

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

0 Hours

Max Age

4 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-15

Primary Completion

2027-04-15

Completion

2028-04-14

Countries

• India

Study Locations