Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

1,500

Participants

Timeline

Start Date

April 15, 2024

Primary Completion Date

April 15, 2027

Study Completion Date

April 14, 2028

Conditions
SepsisPROM, Preterm (Pregnancy)Early-Onset Neonatal SepsisPreterm Premature Rupture of MembranePreterm 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"

Trial Locations (1)

160012

Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh

All Listed Sponsors
collaborator

Lady Hardinge Medical College

OTHER_GOV

collaborator

King George's Medical University

OTHER

collaborator

Indira Gandhi Institute of Child Health

UNKNOWN

collaborator

Institute of Obstetrics and Gynecology

UNKNOWN

collaborator

Government Medical College, Chandigarh

OTHER

collaborator

Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak

OTHER

collaborator

Government Medical College, Aurangabad

OTHER_GOV

collaborator

King Edward Memorial Hospital, Mumbai

OTHER_GOV

lead

Indian Council of Medical Research

OTHER_GOV

NCT06377397 - Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates | Biotech Hunter | Biotech Hunter