Nurses' Knowledge of High-alert Medications in Pediatric CareHAM-AuditNCT07243431
Knowledge About the Administration and Regulation of High Alert Medications Among Nurses in Mansoura University Children's Hospital: A Hospital-wide Audit
An observational study of Nurses' Knowledge of High-alert Medications in Pediatric Care, run by Omar Hamdy at 1 site in Egypt.
Trial summary
This study checks how well nurses at Mansoura University Children's Hospital know about high-alert medications (HAMs). These are drugs that can cause serious harm if given incorrectly. We used a questionnaire to assess their knowledge and identify any gaps. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nurses' Knowledge of High-alert Medications in Pediatric Care
- How many people
- 335 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Feb 2025to 12 Sep 2025
- How long will I take part?
- 6 Weeks
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All registered nurses working at Mansoura University Children's Hospital who are involved in medication administration. The study includes nurses from various departments with at least 6 months of experience. This hospital-wide audit targets frontline healthcare providers responsible for high-alert medication handling in a tertiary pediatric setting.
Who may be able to join
- - Registered nurses working at Mansoura University Children's Hospital.
- Involved in medication administration.
- At least 6 months of experience in the hospital.
Who cannot join
- Non-nursing staff.
- Nurses not involved in direct patient care or medication administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pediatric Medication Safety Revolution: Auditing Nurses' Knowledge on High-Alert Drugs
This study checks how well nurses at Mansoura University Children's Hospital know about high-alert medications (HAMs). These are drugs that can cause serious harm if given incorrectly. We used a questionnaire to assess their knowledge and identify any gaps. The goal is to improve training and reduce medication errors in the hospital.
Read the detailed description
Background:
Medication errors (MEs) are a major cause of patient harm, especially in pediatric settings. High-alert medications (HAMs) are drugs that carry a heightened risk of causing significant patient harm when used in error. Nurses play a critical role in the safe administration of HAMs. This hospital-wide audit aims to evaluate nurses' knowledge regarding the administration and regulation of HAMs at Mansoura University Children's Hospital.
Objectives:
- To assess the level of knowledge about HAMs among nurses.
- To identify factors associated with sufficient knowledge of HAMs.
Methods:
A cross-sectional study was conducted using a self-administered questionnaire distributed to all nurses involved in medication administration at Mansoura University Children's Hospital. The questionnaire covered identification of HAMs, storage, administration protocols, and error prevention strategies. Data was collected from [February to October 2025] and analyzed using descriptive statistics and logistic regression.
Setting:
Mansoura University Children's Hospital, Mansoura, Egypt.
Participants:
All registered nurses working in the hospital and involved in medication administration.
Outcome Measures:
- Primary: Level of knowledge about HAMs (scored as sufficient/insufficient).
- Secondary: Factors associated with sufficient knowledge (e.g., years of experience, training).
- Keywords
- high-alert medications, nurses knowledge, medication errors
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of nurses with sufficient knowledge of high-alert medications
Percentage of nurses scoring ≥70% on the questionnaire assessing knowledge of high-alert medications (identification, administration, storage, and error prevention).
Measured: February 2025 to October 2025
Secondary outcomes (1)
Factors associated with sufficient knowledge of high-alert medications
Identification of factors (e.g., years of experience, training, department) associated with scoring ≥70% on the knowledge questionnaire using multivariate logistic regression.
Measured: February 2025 to October 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start12 Feb 2025
- Primary completion12 Sep 2025
- Study completion12 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurses' Knowledge of High-alert Medications in Pediatric CareStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 335 participants (actual)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Omar Hamdy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Omar Hamdy, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243431
- Sponsor's protocol ID
- R.25.01.3028
- Acronym
- HAM-Audit
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Medication Safety Revolution: Auditing Nurses' Knowledge on High-Alert Drugs
- ClinicalTrials.gov ID
- NCT07243431
- Acronym / sponsor ID
- HAM-Audit / R.25.01.3028
- Keywords
- high-alert medications, nurses knowledge, medication errors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Omar HamdyUniversity, hospital or other
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- 12 Sep 2025 (actual)
- Study completion
- 12 Sep 2025 (actual)
- First posted
- 21 Nov 2025 (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.
This study checks how well nurses at Mansoura University Children's Hospital know about high-alert medications (HAMs). These are drugs that can cause serious harm if given incorrectly. We used a questionnaire to assess their knowledge and identify any gaps. The goal is to improve training and reduce medication errors in the hospital.
Detailed description
Background:
Medication errors (MEs) are a major cause of patient harm, especially in pediatric settings. High-alert medications (HAMs) are drugs that carry a heightened risk of causing significant patient harm when used in error. Nurses play a critical role in the safe administration of HAMs. This hospital-wide audit aims to evaluate nurses' knowledge regarding the administration and regulation of HAMs at Mansoura University Children's Hospital.
Objectives:
- To assess the level of knowledge about HAMs among nurses.
- To identify factors associated with sufficient knowledge of HAMs.
Methods:
A cross-sectional study was conducted using a self-administered questionnaire distributed to all nurses involved in medication administration at Mansoura University Children's Hospital. The questionnaire covered identification of HAMs, storage, administration protocols, and error prevention strategies. Data was collected from [February to October 2025] and analyzed using descriptive statistics and logistic regression.
Setting:
Mansoura University Children's Hospital, Mansoura, Egypt.
Participants:
All registered nurses working in the hospital and involved in medication administration.
Outcome Measures:
- Primary: Level of knowledge about HAMs (scored as sufficient/insufficient).
- Secondary: Factors associated with sufficient knowledge (e.g., years of experience, training).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All registered nurses working at Mansoura University Children's Hospital who are involved in medication administration. The study includes nurses from various departments with at least 6 months of experience. This hospital-wide audit targets frontline healthcare providers responsible for high-alert medication handling in a tertiary pediatric setting.
Key inclusion criteria (3 listed)
- - Registered nurses working at Mansoura University Children's Hospital.
- Involved in medication administration.
- At least 6 months of experience in the hospital.
Key exclusion criteria (2 listed)
- Non-nursing staff.
- Nurses not involved in direct patient care or medication administration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of nurses with sufficient knowledge of high-alert medications
Time frame: February 2025 to October 2025
Percentage of nurses scoring ≥70% on the questionnaire assessing knowledge of high-alert medications (identification, administration, storage, and error prevention).
1 secondary outcome
Factors associated with sufficient knowledge of high-alert medications
Time frame: February 2025 to October 2025
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 21 Nov 2025.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Nurses' Knowledge of High-alert Medications in Pediatric Care, run by Omar Hamdy 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 3 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 21 Nov 2025. 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?
Proportion of nurses with sufficient knowledge of high-alert medications (time frame: February 2025 to October 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2025.