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Search / Trial NCT03932123

Antibiotic Therapy for Early Onset Neonatal Sepsis

Launched by SHANDONG UNIVERSITY · Apr 29, 2019

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating the use of antibiotics to treat early onset neonatal sepsis, a serious infection that can affect newborns within the first few days of life. The goal is to determine how effective and safe these antibiotics are, especially considering that current treatment recommendations are not always followed in many places around the world. The first-line treatment being studied includes a combination of penicillin and gentamicin.

To participate in this trial, babies must be less than 72 hours old and meet specific treatment guidelines for early onset neonatal sepsis. Parents will need to give written consent for their child to be part of the study. If a baby has a serious congenital condition or is expected to have a very short life, they may not be eligible. Participants will receive standard antibiotic treatment and will be monitored throughout the trial to ensure their safety and health. This study aims to improve treatment options for newborns with this condition, ultimately helping to save lives.

Gender

ALL

Eligibility criteria

  • 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.

About Shandong University

Shandong University is a prestigious research institution located in Jinan, China, renowned for its commitment to advancing medical and scientific knowledge through innovative research and clinical trials. With a strong emphasis on interdisciplinary collaboration, the university fosters an environment conducive to groundbreaking studies that address critical healthcare challenges. Shandong University actively engages in clinical research to evaluate new therapies and interventions, contributing to the global body of medical literature and enhancing patient care. Its dedicated team of researchers and clinicians ensures adherence to the highest ethical standards and regulatory compliance, positioning the university as a key player in the field of clinical research.

Locations

Tianjin, Tianjin, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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