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Neonatal SepsisNCT05692128

Frequency and Severity of Thrombocytopenia in Neonatal Sepsis

An observational study of Neonatal Sepsis, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 1 day to 28 days
Conditions the study is for
Neonatal Sepsis
What is being tested?
Hematological and chemistry tests
How many people
50 participants
Where
No sites listed yet
Study dates
Sep 2023to Mar 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 28 days
  • All sexes
  • No healthy volunteers
  • Child

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

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet.

Ragab M Amin, Resident p contact

+201092856285

ragab.aaamin@gmail.com

Yasser F Abd elrahim, As. p contact

+20111 116 8123

Yasser.rezk@med.au.edu.eg

About this study

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

Read the detailed description

Early-onset sepsis remains a common and serious problem for neonates, especially preterm infants. Group B streptococcus (GBS) is the most common etiologic agent, while Escherichia coli is the most common cause of mortality. Current efforts toward maternal intrapartum antimicrobial prophylaxis have significantly reduced the rates of GBS disease but have been associated with increased rates of Gram negative infections, especially among very-low-birth-weight infants .

The diagnosis of neonatal sepsis is based on a combination of clinical presentation, the use of nonspecific markers, including C-reactive protein, blood cultures, CBC , ESR. .Its miles assessed that sepsis develops in 20% of neonates, of which 1% die in the early days... Empirical treatment should be based on local patterns of antimicrobial resistance but typically consists of the use of ampicillin and gentamicin or ampicillin and cefotaxime if meningitis is suspected, until the etiologic agent has been identified. Current research is focused primarily on development of vaccines against GBS. It encompasses various systemic infections of the newborn such as septicemia, meningitis, pneumonia, pyogenic arthritis, osteomyelitis and urinary tract infections. Sepsis is the commonest cause of neonatal mortality; it is responsible for about 30-50% of the total neonatal deaths in developing countries. It is estimated that up to 20% of neonates develop sepsis and approximately 1% die of sepsis related causes. Sepsis related mortality is largely preventable with rational antimicrobial the rapid and aggressive supportive care .

. Based on the onset, sepsis is divided into three categories: early-onset sepsis (fewer than three days of age), late-onset sepsis (LOS) (at 3-28 days of age), and late late-onset sepsis (at 29-120 days of age). Among all three types, late-onset sepsis (LOS) is frequent, particularly in VLBW neonates. One of the early indicators for neonatal sepsis is thrombocytopenia . Thrombocytopenia is one of the most common hematological disorders at newborn age, affecting the majority of neonates admitted to the NICU . Neonates admitted to NICUs develop thrombocytopenia in 20%-35% of all admissions, and a hike in percentage is noted with a drop in gestational age . The majority of neonates present with mild to moderate thrombocytopenia. Sepsis in the newborn is one of the chief causes of thrombocytopenia in neonates, and it can become very severe and can increase the risk of bleeding within 24 hours after developing an infection . The exact mechanism of low platelets in neonatal sepsis is unknown, but it has been proposed that sepsis causes endothelial injury, which in turn triggers the reticuloendothelial system. Platelet consumption exceeds production and causes thrombocytopenia . Thrombocytopenia and neonatal sepsis associations have been highlighted by recognizing thrombocytopenia as the prominent key risk feature for sepsis-related fatalities in neonates . An observational study by Noreen et al. showed that the frequency of thrombocytopenia is higher in neonates admitted to the NICU for any reason . Neonatal sepsis must not be considered as a homogenous entity, as it spurns both the pathogenic and clinical variations among numerous causative microorganisms and clinical syndromes and features of septicemia. No local study has been done in the recent past that emphasizes the incidence of thrombocytopenia in neonatal sepsis. In this research, we will present the characteristics of thrombocytopenia related to sepsis in both gram-negative and gram-positive cells. This will be beneficial for early diagnosis and treatment, predicting morbidity and mortality.

The results of this study will provide us with local statistics on the magnitude of neonatal thrombocytopenia in sepsis, and this will provide a window for further research

Conditions
Neonatal Sepsis
Being tested
Hematological and chemistry tests
Medical subject headings
Neonatal Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hematological and chemistry testsOther

    Laboratory tests

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2023
  2. Study startSep 2023 (estimated)
  3. Primary completionJan 2024 (estimated)
  4. Study completionMar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05692128
Sponsor's protocol ID
Thrombocytopenia neonatal seps
Status last verified
Jul 2023
First submitted
11 Jan 2023
Last updated
24 Jul 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 24396135

Questions about this trial

What is this clinical trial studying?

An observational study of Neonatal Sepsis, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ragab M Amin, Resident p (+201092856285, ragab.aaamin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Find out frequency of cases admited to NICU with neonatal sepsis and have thrombocytopenia and document it's severity (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05692128, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.

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