NCT05692128

Brief Summary

The aim of our study was to find the frequency of thrombocytopenia and its severity in neonates with sepsis

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

January 11, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 20, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

4 months

First QC Date

January 11, 2023

Last Update Submit

July 21, 2023

Conditions

Neonatal Sepsis

Outcome Measures

Primary Outcomes (1)

  • Find out frequency of cases admited to NICU with neonatal sepsis and have thrombocytopenia and document it's severity

    Detect frequency and severity of thrombocytopenia in cases admitted in NICU with neonatal sepsis

    Baseline

Interventions

Hematological and chemistry testsOTHER

Laboratory tests

Eligibility Criteria

Age1 Day - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All neonates admitted to NICU sufferd from neonatal sepsis and have thrombocytopenia

You may qualify if:

  • All neonates less than 28 days old, of both genders, and positive blood culture were included.

You may not qualify if:

  • Those with a mother's history of ITP, SLE, or other autoimmune disorders on medication during pregnancy (sulfonamides, quinine, quinidine, thiazides, tolbutamide, vancomycin, hydralazine, and heparin) and neonates with a history of bleeding disorders in the family, trisomies, or Turner/Noonan's syndromes were excluded. All neonates less than 28 days old, of both genders were included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Simonsen KA, Anderson-Berry AL, Delair SF, Davies HD. Early-onset neonatal sepsis. Clin Microbiol Rev. 2014 Jan;27(1):21-47. doi: 10.1128/CMR.00031-13.

    PMID: 24396135BACKGROUND

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

Study Officials

  • Amal A Soliman

    Assiut University

    STUDY CHAIR

Central Study Contacts

Ragab M Amin, Resident p

CONTACT

+201092856285ragab.aaamin@gmail.com

Yasser F Abd elrahim, As. p

CONTACT

+20111 116 8123Yasser.rezk@med.au.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 11, 2023

First Posted

January 20, 2023

Study Start

September 1, 2023

Primary Completion

January 1, 2024

Study Completion

March 1, 2024

Last Updated

July 24, 2023

Record last verified: 2023-07