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

NCT06197269 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2024-08-13

No results posted yet for this study

Summary

Objective of the study is to compare the efficacy and safety of 'Short duration antibiotic' (72hrs) and 'Standard duration antibiotic'(5 - 7days) in preterm neonates ( \>28weeks and \>1000grams ) with culture negative early onset sepsis.

Conditions

  • Early-Onset Neonatal Sepsis
  • Antibiotic Stewardship

Interventions

OTHER

Short duration antibiotics

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

OTHER

Standard duration antibiotics

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

Sponsors & Collaborators

  • Lady Hardinge Medical College

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
28 Weeks
Max Age
36 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-15
Primary Completion
2024-02-14
Completion
2024-04-14

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06197269 on ClinicalTrials.gov