Trials Sponsors Conditions Drugs Pricing

Conditions

Antibiotic Stewardship Early-Onset Neonatal Sepsis

Outcome Measures

Primary Outcomes (1)

Incidence of 'Treatment Failure'
New onset appearance of clinical signs and symptoms requiring initiation of antibiotics
15 days of stopping antibiotics

Secondary Outcomes (3)

Mortality
Till 1 month of life
Need for additional courses of antibiotic therapy
Till 1 month of life
Length of hospital stay
From date of birth until date of death or discharge whichever come assessed till 1 month of life

Study Arms (2)

Short duration antibiotic

EXPERIMENTAL

antibiotic therapy will be stopped at the time of randomization i.e. 72 hrs after starting treatment

Other: Short duration antibiotics

Standard duration antibiotic

ACTIVE COMPARATOR

Antibiotics will be continued for 5-7 days more, 72 hrs after starting treatment.

Other: Standard duration antibiotics

Interventions

Short duration antibioticsOther

antibiotic therapy will be stopped at the time of randomization i.e. 72 hrs after starting treatment

Short duration antibiotic

Standard duration antibioticsOther

Antibiotics will be continued for 5-7 days more, 72 hrs after starting treatment.

Standard duration antibiotic

Eligibility Criteria

Age28 Weeks - 36 Weeks

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

All Preterm neonates (Gestational age \>28weeks and \>1000grams)
age less than 72hours of life

Sponsors & Collaborators

Lady Hardinge Medical College
Governmentlead

Study Sites (1)

Lady Hardinge Medical college

New Delhi, National Capital Territory of Delhi, 110001, India

MeSH Terms

Conditions

Neonatal Sepsis

Condition Hierarchy (Ancestors)

SepsisInfectionsInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Enrollment

75 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER GOV
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Director Professor & Head, Department of Neonatology

Study Record Dates

First Submitted

December 26, 2023

First Posted

January 9, 2024

Study Start

April 15, 2022

Actual (reported)

Efficacy And Safety Of Short Course Antibiotic Therapy In Preterm Neonates With Early Onset Sepsis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Short duration antibiotic

Standard duration antibiotic

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Short duration antibiotic

Standard duration antibiotic

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations