Neonatal SepsisNCT04039152
Clinical Impact of an Antibiotic Stewardship Program in a Neonatal Intensive Care Unit
An observational study of Neonatal Sepsis, run by Assiut University at 1 site in Egypt.
Trial summary
Antimicrobial resistance is one of the biggest and most urgent threat to global health. Initiating antimicrobial stewardship programs is one of the main efforts to control antimicrobial resistance. Read more about this study
- Who is it for?
- Ages 1 day to 30 daysHealthy volunteers can take part
- Conditions the study is for
- Neonatal Sepsis
- What is being tested?
- locally adapted neonatal sepsis treatment protocol
- How many people
- 1,200 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jan 2019to 31 Dec 2020
- 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 30 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Neonates admitted to NICU and received antibiotics for more than 72 hours
Who may be able to join
- Received antibiotics for more than 72 hours.
Who cannot join
- Hospital stay was less than 72 hours.
- Did not receive any antibiotics during hospital stay.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Impact of an Antibiotic Stewardship Program in a Neonatal Intensive Care Unit at a Tertiary Care Hospital: A Prospective Quasi Experimental Clinical Study
Antimicrobial resistance is one of the biggest and most urgent threat to global health. Initiating antimicrobial stewardship programs is one of the main efforts to control antimicrobial resistance. Implementing these programs in neonatal intensive care units (NICU)is very important and crucial despite of its difficulty, where antibiotics are used extensively. The aim of present study was to assess the clinical impact of implementing antibiotic stewardship program interventions at NICU.
Read the detailed description
Background:
Implementing an antimicrobial stewardship program is one of the main efforts to control antimicrobial resistance. The present study aimed to assess the clinical impact of the antibiotics stewardship program (ASP) in the neonatal intensive care unit (NICU) of Assiut University Children's Hospital.
Methods:
The study was conducted in two phases from January 2019 to June 2020. The pre-ASP phase (603 patients) included making NICU-specific antibiograms, choosing the antibiotic use evaluation measures, conducting antibiotic use evaluations, and designing the ASP. The ASP intervention phase (597 patients) included implementation of the ASP, which involved modifying the neonatal sepsis treatment protocol according to the local antibiotic susceptibility patterns and measuring its clinical outcomes.
Results:
The ASP intervention phase showed a significant increase in the number of C-reactive protein tests, microbiological cultures/patient, the number of patients taking definitive therapy, and the number of pharmacist interventions/patient. The prescribing rates of antibiotics and their consumption levels were changed according to the NICU-specific antibiogram. There was a significant reduction in the 14-day and 28-day mortality of patients with late-onset sepsis after modifying the neonatal sepsis treatment protocol in the ASP intervention phase.
Conclusion:
ASP implementation was successful in improving antibiotic prescribing and patients outcomes.
- Conditions
- Neonatal Sepsis
- Being tested
- locally adapted neonatal sepsis treatment protocol
- Keywords
- Antibiotics, Antimicrobial resistance, Antibiotic stewardship program, Neonatal intensive care unit, Neonatal sepsis
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
locally adapted neonatal sepsis treatment protocolOther
Also called implementing a new antibiotic dosing protocol, increasing the number of ordered microbiological cultures, the number of C-reactive protein (CRP) tests per patient.
the neonatal sepsis treatment protocol was modified according to the local antibiotics susceptibility patterns
| Study group | Role | What they receive |
|---|---|---|
| The pre-antibiotics stewardship program phase | This phase included making NICU-specific antibiograms, choosing the antibiotic use evaluation measures, conducting antibiotic use evaluations, and designing the antibiotics stewardship program (ASP). | |
| The antibiotics stewardship program intervention phase | The ASP intervention phase included implementation of the ASP, which involved modifying the neonatal sepsis treatment protocol according to the local antibiotic susceptibility patterns and measuring its clinical outcomes. Receives: Other: locally adapted neonatal sepsis treatment protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
14-days mortality in each group
Number of patients who died from neonatal sepsis at the 14th day of their hospital stay was compared in the Pre-ASP phase and the ASP intervention phase
Measured: 6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phase
28-days mortality in each group
Number of patients who died from neonatal sepsis at the 28th day of their hospital stay was compared in the Pre-ASP phase and the ASP intervention phase
Measured: 6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phase
Secondary outcomes (2)
Average Length of hospital stay in each group
In days
Measured: 6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phase
30-day readmission in each group
number of patients readmitted within 30 days from discharge
Measured: 6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start3 Jan 2019
- Primary completion30 Jun 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal SepsisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neveen Hassan, Assiut University
- Investigators
- Neveen H. Abdelaal, M.sc., Principal investigator, Department of Pharmacy and Medical Supplies, Assiut University Children's Hospital, EgyptNafisa H. Abdel Aziz, PhD, Study chair, Department of Pediatrics, Faculty of Medicine, Assiut University, EgyptAsmaa M. Abdelaziz, PhD, Study chair, Department of Clinical Pathology, Faculty of Medicine, Assiut University, EgyptSahar B. Khalil, PhD, Study director, Department of Clinical Pharmacy, Faculty of Pharmacy, Assiut University, EgyptMohamed M Abdel-Latif, PhD, Study director, Department of Clinical Pharmacy, Faculty of Pharmacy, Assiut University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039152
- Sponsor's protocol ID
- AssiutUU
- Status last verified
- Apr 2024
- First submitted
- 29 Jul 2019
- Last updated
- 23 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will not be shared
Publications
Abdelaal NH, Aziz NHRA, Abdelaziz AM, Khalil SBH, Abdel-Latif MMM. Clinical impact of an antibiotic stewardship program in a neonatal intensive care unit at a tertiary care hospital: a prospective quasi-experimental clinical study. J Pharm Health Care Sci. 2025 Sep 23;11(1):81. doi: 10.1186/s40780-024-00404-3.
PubMed 40988069
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of an Antibiotic Stewardship Program in a Neonatal Intensive Care Unit at a Tertiary Care Hospital: A Prospective Quasi Experimental Clinical Study
- ClinicalTrials.gov ID
- NCT04039152
- Acronym / sponsor ID
- AssiutUU
- Conditions
- Neonatal Sepsis
- Keywords
- Antibiotics, Antimicrobial resistance, Antibiotic stewardship program, Neonatal intensive care unit, Neonatal sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 31 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Antimicrobial resistance is one of the biggest and most urgent threat to global health. Initiating antimicrobial stewardship programs is one of the main efforts to control antimicrobial resistance. Implementing these programs in neonatal intensive care units (NICU)is very important and crucial despite of its difficulty, where antibiotics are used extensively. The aim of present study was to assess the clinical impact of implementing antibiotic stewardship program interventions at NICU.
Detailed description
Background:
Implementing an antimicrobial stewardship program is one of the main efforts to control antimicrobial resistance. The present study aimed to assess the clinical impact of the antibiotics stewardship program (ASP) in the neonatal intensive care unit (NICU) of Assiut University Children's Hospital.
Methods:
The study was conducted in two phases from January 2019 to June 2020. The pre-ASP phase (603 patients) included making NICU-specific antibiograms, choosing the antibiotic use evaluation measures, conducting antibiotic use evaluations, and designing the ASP. The ASP intervention phase (597 patients) included implementation of the ASP, which involved modifying the neonatal sepsis treatment protocol according to the local antibiotic susceptibility patterns and measuring its clinical outcomes.
Results:
The ASP intervention phase showed a significant increase in the number of C-reactive protein tests, microbiological cultures/patient, the number of patients taking definitive therapy, and the number of pharmacist interventions/patient. The prescribing rates of antibiotics and their consumption levels were changed according to the NICU-specific antibiogram. There was a significant reduction in the 14-day and 28-day mortality of patients with late-onset sepsis after modifying the neonatal sepsis treatment protocol in the ASP intervention phase.
Conclusion:
ASP implementation was successful in improving antibiotic prescribing and patients outcomes.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The pre-antibiotics stewardship program phase | – | –This phase included making NICU-specific antibiograms, choosing the antibiotic use evaluation measures, conducting antibiotic use evaluations, and designing the antibiotics stewardship program (ASP). |
| The antibiotics stewardship program intervention phase | – | Other: locally adapted neonatal sepsis treatment protocolThe ASP intervention phase included implementation of the ASP, which involved modifying the neonatal sepsis treatment protocol according to the local antibiotic susceptibility patterns and measuring its clinical outcomes. |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Neonates admitted to NICU and received antibiotics for more than 72 hours
Key inclusion criteria (1 listed)
- Received antibiotics for more than 72 hours.
Key exclusion criteria (2 listed)
- Hospital stay was less than 72 hours.
- Did not receive any antibiotics during hospital stay.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| locally adapted neonatal sepsis treatment protocolAlso: implementing a new antibiotic dosing protocol, increasing the number of ordered microbiological cultures, the number of C-reactive protein (CRP) tests per patient.the neonatal sepsis treatment protocol was modified according to the local antibiotics susceptibility patterns | Other | The antibiotics stewardship program intervention phase |
Primary outcome
14-days mortality in each group
Time frame: 6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phase
Number of patients who died from neonatal sepsis at the 14th day of their hospital stay was compared in the Pre-ASP phase and the ASP intervention phase
28-days mortality in each group
Time frame: 6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phase
Number of patients who died from neonatal sepsis at the 28th day of their hospital stay was compared in the Pre-ASP phase and the ASP intervention phase
2 secondary outcomes
Average Length of hospital stay in each group
Time frame: 6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phase
30-day readmission in each group
Time frame: 6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phase
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Derived from this study: PubMed 40988069Abdelaal NH, Aziz NHRA, Abdelaziz AM, Khalil SBH, Abdel-Latif MMM. Clinical impact of an antibiotic stewardship program in a neonatal intensive care unit at a tertiary care hospital: a prospective quasi-experimental clinical study. J Pharm Health Care Sci. 2025 Sep 23;11(1):81. doi: 10.1186/s40780-024-00404-3.
- Individual participant dataSharing planned: No. Participant data will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neveen H. Abdelaal, M.sc. principal investigator
Department of Pharmacy and Medical Supplies, Assiut University Children's Hospital, Egypt
Nafisa H. Abdel Aziz, PhD study chair
Department of Pediatrics, Faculty of Medicine, Assiut University, Egypt
Asmaa M. Abdelaziz, PhD study chair
Department of Clinical Pathology, Faculty of Medicine, Assiut University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Sepsis, run by Assiut University at 1 site in Egypt.
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 2 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: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
14-days mortality in each group (time frame: 6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phase). The study lists 2 primary outcomes in all. 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 NCT04039152, 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 23 Apr 2024.