Bacteriological Profile and Antibiotic Sensitivity in Neonatal Intensive Care Unit At Assuit University Children Hospital

March 21, 2025 updated by: Madleen Thabet Hofni Basali, Assiut University
The study aims to assess the bacteriological profile and antibiotic sensitivity in NICU of pediatric hospital of assuit university.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The World Health Organization (WHO) defines nosocomial infections (NI), also referred to as healthcare-associated infections (HAI's), as illnesses that develop in a patient while they are receiving treatment in a hospital or other healthcare institution but were neither present nor incubating at the time of admission . The symptoms should appear at least 2 calendar days admission to the hospital . The severity of the illness, prematurity, congenital defects, systemic diseases, degree of invasive monitoring, indiscriminate use of antibiotics, failures in sterilisation and disinfection techniques, and the type of diagnostic procedures all directly increase the risk of nosocomial infection in neonates . Long hospital stays, permanent incapacity, heightened antibiotic resistance in microorganisms, significant additional expenses for health systems, high costs for patients and their families, and avoidable deaths are all consequences of nosocomial infections . The most commonly encountered HAI's are central line associated blood stream infection (CLABSI), ventilator associated pneumonia (VAP), catheter associated urinary tract infection (CAUTI) and surgical site infections (SSI's). The other possible HAI's include meningitis, conjunctivitis and skin infections . The symptoms of health-associated infections are typically nonspecific and resemble those of other frequent neonatal diseases, including metabolic, respiratory, and thermoregulatory problems.However, improving an infant's prognosis requires prompt care. Typically, antimicrobial treatment is started without laboratory verification . Annually, more than a million neonatal deaths occur globally, with 30%-40% of these fatalities in low-resource nations linked to infections acquired in hospitals. In the NICU, bacteria, fungi, and viruses can persist and contaminate surfaces, equipment, and the surrounding environment for different lengths of time . In assuit university there is a study that has done about the incidence and risk factors of health care associated infections in NICU and it stated that out of 150 neonates , 107 developed nosocomial infection ,As regards the microbial profile and the distribution of isolated microorganisms from positive blood cultures, the most common pathogens were Staphylococcus aureus (22.7%) .The most common isolated microorganisms from positive endotracheal aspirate cultures were Klebsiella spp. (16%) . A study from Cairo university included 153 cases of neonatal sepsis; 63 (41.2%) EOS and 90 (58.8%) LOS. The majority of the neonates had very low or moderately low birth weight (90.9%). All neonates received first-line antibiotics in the form of ampicillin-sulbactam, and gentamicin. Second-line antibiotics were administered to 133 neonates (86.9%) as vancomycin and imipenem-cilastatin. Mortalities were more common among EOS group (p < 0.017). Positive blood cultures were detected in 61 neonates (39.8%) with a total number of 66 cultures. The most commonly encountered organisms were Klebsiella MDR and CoNS (31.8% each). Klebsiella MDR was the most predominant organism in EOS (28.9%), while CoNS was the most predominant in LOS (39.2%) The detected organisms were divided into 3 families; Enterobacteriaceae, non-fermenters, and Gram-positive family. There 3 families were 100% resistant to ampicillin. The highest sensitivity in Enterobacteriaceae and Non-fermenters was for colistin and polymyxin-B. An HSS of 3-8 had a sensitivity and specificity of 62.3% and 57.6%, respectively for diagnosis of culture-proven sepsis . A study from Ain Shams university included a 1-year records of a total of 1280 pathogens were studied. The highest number of pathogens were isolated from blood cultures (44.84%), followed by urine (41.41%) then wound swabs (13.75%). Gram-negative isolates (57.5%) were more prevalent than gram-positive ones (31.1%). The most frequently isolated pathogens were Klebsiella spp. (22.5%), Escherichia coli (13.4%), and Coagulase-negative Staphylococci (12.5%). The highest percentage of resistance among gram-positive organisms was exhibited by penicillin (89.5%) followed by erythromycin (83.98%) and then cefoxitin (76.52%). None of the isolates showed resistance to linezolid and resistance to vancomycin was minimal (2.62%). Gram-negative isolates exhibited high overall resistance to all used antibiotic classes. The least frequency of resistance was recorded against nitrofurantoin (52.5%), amikacin (58.01%), followed by imipenem (59.78%) and meropenem (61.82%). All isolates of Pseudomonas and Acinetobacter showed 100% susceptibility to colistin . Therefore, this study was done to know the bacteriological profile and the culture sensitivity of nosocomial infection in neonatal intensive care unit in pediatric hospital of assuit university.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
134

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion criteria :

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Bacteriological profile and antibiotic sensitivity of the nosocomial infection in neonatal intensive care unit at Assuit University Children hospital
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zeinab Mohamed Mohey, Professor of pediatrics, Assiut University
  • Principal Investigator: Safwat Mohamed Abdel_Aziz, Assistant professor of pediatr, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Ab sensitivity in neonates

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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