Antibiotic Therapy for Early Onset Neonatal Sepsis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-05

Study Completion Date

2025-12-31

Brief Summary

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Antibiotic therapy for early onset neonatal sepsis recommended by international guidelines and relevant studies is only kind of treatment regimen that penicillin G/ penicillin/ampicillin combined with gentamicin as the first-line treatment regimen. However, it is not applicable to the clinical practice in many countries and regions. We aim to study efficacy and safety of antibiotics in the treatment of early onset neonatal sepsis.

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Detailed Description

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Conditions

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Early Onset Neonatal Sepsis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Piperacillin and tazobactam, azlocillin, latamoxef, meropenem, vancomycin，cefotaxime

Efficacy and safety of antibiotics

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age: postnatal age ≤ 72h;
* Meets NICE guidelines for using antibiotics to treat EONS;
* Azlocillin used as part of antimicrobial treatment;
* Parental written consent.

Exclusion Criteria

* Expected survival time less than the treatment cycle;
* Major congenital malformations;
* Undergoing surgery within the first week of life;
* Receiving other systemic trial drug therapy;
* Other factors that the researcher considers unsuitable for inclusion.

Minimum Eligible Age

0 Days

Maximum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No