NCT06891768

Brief Summary

The study aims to assess the bacteriological profile and antibiotic sensitivity in NICU of pediatric hospital of assuit university.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started May 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
May 2025Jun 2026

First Submitted

Initial submission to the registry

March 18, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

March 18, 2025

Last Update Submit

March 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Bacteriological profile and antibiotic sensitivity of the nosocomial infection in neonatal intensive care unit at Assuit University Children hospital

    Baseline

Interventions

Blood cultureDIAGNOSTIC_TEST

Blood culture for bacteriological profile and antibiotic sensitivity

Eligibility Criteria

Age2 Days - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Neonates that suspected to have nosocomial infection in neonatal intensive care unit at Assuit University Children hospital

You may qualify if:

  • Neonates \<28 days of life .
  • Hospital stay \>48 h .
  • Neonates without signs of sepsis at time of admission .
  • Accepted to participate in this study .

You may not qualify if:

  • Neonates \>28 days of life .
  • Hospital stay \<48 h .
  • Neonates with neonatal sepsis at time of admission.
  • Refused to participate in this study .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Fahim NAE. Prevalence and antimicrobial susceptibility profile of multidrug-resistant bacteria among intensive care units patients at Ain Shams University Hospitals in Egypt-a retrospective study. J Egypt Public Health Assoc. 2021 Mar 29;96(1):7. doi: 10.1186/s42506-020-00065-8.

    PMID: 33779849BACKGROUND
  • 7. Mahmoud Mohammed GSED, Shoriet AH, Abdel-Aziz SM. Incidence and risk factors of health-care-associated infection in the neonatal intensive care unit of Assiut University Children's Hospital. Journal of Current Medical Research and Practice. 2021;6(1):48-53.

    BACKGROUND
  • 6. Salem GA. Bacterial contamination in neonatal intensive care units in Misurata, Libya: analysis of causative organisms, biofilm formation, and antimicrobial susceptibility. European Journal of Microbiology and Infectious Diseases. 2024;1(2):66-

    BACKGROUND
  • Silva ACBE, Anchieta LM, Rosado V, Ferreira J, Clemente WT, Coelho JS, Mourao PHO, Romanelli RMC. Antimicrobial use for treatment of healthcare-associated infections and bacterial resistance in a reference neonatal unit. J Pediatr (Rio J). 2021 May-Jun;97(3):329-334. doi: 10.1016/j.jped.2020.06.001. Epub 2020 Jun 24.

    PMID: 32592659BACKGROUND
  • 4. Koech CC, Rono SJ, Ngeiywa MM, Jeruto P. Neonatal Factors Predisposing Neonates to Nosocomial Infections at Moi Teaching and Referral Hospital. International Journal of Education, Science and Social Sciences. 2024;3(2):35-43.

    BACKGROUND
  • 3. Shwetabh R, Upadhyay MR, Upadhyay R. Aetiological Agents in Neonatal Nosocomial Sepsis and their Sensitivity Pattern from a Tertiary Care Hospital, Odisha, India: A Crosssectional Study. Seizure. 2022;6:6.

    BACKGROUND
  • 2. Moses SS, Kuruvilla TS, Praveen B. Clinicomicrobiological profile of healthcare associated infections in a neonatal intensive care unit and its relation with environmental surveillance. Panacea Journal of Medical Sciences. 2023;13(1):36-41 .

    BACKGROUND
  • 1. Hogeveen M, Heijting I, Jansen S, de Boode W, Hopman J, Overbeek MGD, et al. Nosocomial infections in neonatal care: a scoping review protocol of published surveillance case definitions. 2021.

    BACKGROUND

MeSH Terms

Interventions

Blood Culture

Intervention Hierarchy (Ancestors)

Microbiological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Zeinab Mohamed Mohey, Professor of pediatrics

    Assiut University

    PRINCIPAL INVESTIGATOR
  • Safwat Mohamed Abdel_Aziz, Assistant professor of pediatr

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Madleen Thabet Hofni

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

March 18, 2025

First Posted

March 24, 2025

Study Start

May 1, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

March 25, 2025

Record last verified: 2025-03