Hydrocephalus in ChildrenNCT05796713
Barriers to Patients' Early Presentation, Diagnosis and Treatment in Childhood Hydrocephalus
An observational study of Hydrocephalus in Children, run by Lagos State University at 1 site in Nigeria.
Trial summary
Patient with childhood hydrocephalus (HC) tend to present late in Low medium income countries (LMICs). This project will study the barriers leading to patients' and health system delay in patients with childhood HC. This will be done via a quantitative and qualitative study analysis. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Hydrocephalus in Children
- What is being tested?
- Hydrocephalus
- How many people
- 100 participants
- Where
- 1 siteNigeria
- Study dates
- 1 Mar 2023to 27 Jan 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 Up to 5 years
- All sexes
- Child
Study population: Patients who present at the Lagos State University Teaching Hospital, Ikeja, Lagos for management of hydrocephalus
Who may be able to join
- All patients less than 5 years of age with HC confirmed with either magnetic resonance or computerized tomographic images
- Patients' parents' inclusion criteria will be parents (Guardians) of children with radiologically confirmed HC with either magnetic resonance or computerized tomographic images.
- Hospital staff members, who have been working within the Neurosurgical unit for at least 5 years.
Who cannot join
- All patents not investigated or operated at our centre
- Patients older than 5 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Quantitative and Qualitative Analysis of the Barriers to Patients' Early Presentation, Diagnosis and Treatment in Childhood Hydrocephalus
Patient with childhood hydrocephalus (HC) tend to present late in Low medium income countries (LMICs). This project will study the barriers leading to patients' and health system delay in patients with childhood HC. This will be done via a quantitative and qualitative study analysis. The data will be collected prospectively.
Read the detailed description
Children less than 5 years of age with HC confirmed with either magnetic resonance or computerized tomographic images will be recruited. In addition, Hospital staff members, who have been working within the Neurosurgical unit for at least 5 years will be interviewed.
The patients' data that will be collected will include gender, age at presentation, socioeconomic class of parents (or guardians), religion, referral source, presenting complaint with its duration, physical findings, ventricular diameter. The Pre-presentation symptoms interval (PPI) will be defined as the number of days between the onset of symptoms and first presentation at any type of healthcare service centre (including primary healthcare centre, secondary health institutions); Presentation Interval (PI)- Number of days from symptoms to presenting at Neurosurgical centre; Pre-diagnostic interval (PDI) will be defined as the interval in days between symptoms and completion of pre-operative investigations. Patient interval (PI) will be defined as the number of days from the onset of symptoms and patient's first contact with the Neurosurgical center. Hospital interval (HI)- number of days from completion of investigations to surgical intervention. The collected data will be analyzed according to qualitative conventional content analysis. Nvivo software version 13 and Statistical Product and Service Solutions (SPSS) version 23 will be used for data analysis.
- Conditions
- Hydrocephalus in Children
- Being tested
- Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocephalusOther
Interview
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Presentation time in days
Time in days, from the onset of symptoms to the time the patient seeks medical advice.
Measured: 14 days
Diagnostic delay in days
Time in days between the patient's presentation and the confirmation of the diagnosis, in days
Measured: 14 days
Treatment delay in days
The duration (in days) between the diagnosis and initiation of treatment
Measured: 14 days
Secondary outcomes (3)
Treatment outcome as perceived by parents/caregivers
Effectiveness of the treatment in improving patient outcomes using a questionnaire (5-point Likert scale based survey questions with higher scores meaning better outcome)
Measured: 4 weeks
Parents/caregivers satisfaction
The parent's satisfaction with the quality of care received using a questionnaire (5-point Likert scale based survey questions with higher scores meaning better outcome)
Measured: 4 weeks
Reason for delay in presentation, diagnosis and treatment
As described by the parents and hospital staff
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start1 Mar 2023
- Primary completion27 Jan 2024
- Study completion27 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hydrocephalus in ChildrenStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lagos State University
- Sponsor type
- University, hospital or other
- Collaborators
- Hydrocephalus Association
- Responsible party
- Principal investigator, Olufemi Idowu, Lagos State University
- Investigators
- Olufemi Idowu, FWACS, FACS, Principal investigator, Lagos State University Teaching Hospital, Ikeja, Lagos, Nigeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796713
- Sponsor's protocol ID
- 2023/Hydro
- Status last verified
- Dec 2025
- First submitted
- 7 Mar 2023
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data on request
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Quantitative and Qualitative Analysis of the Barriers to Patients' Early Presentation, Diagnosis and Treatment in Childhood Hydrocephalus
- ClinicalTrials.gov ID
- NCT05796713
- Acronym / sponsor ID
- 2023/Hydro
- Conditions
- Hydrocephalus in Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Lagos State UniversityUniversity, hospital or other
- Collaborators
- Hydrocephalus Association
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 27 Jan 2024 (actual)
- Study completion
- 27 Jan 2024 (actual)
- First posted
- 3 Apr 2023 (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.
Patient with childhood hydrocephalus (HC) tend to present late in Low medium income countries (LMICs). This project will study the barriers leading to patients' and health system delay in patients with childhood HC. This will be done via a quantitative and qualitative study analysis. The data will be collected prospectively.
Detailed description
Children less than 5 years of age with HC confirmed with either magnetic resonance or computerized tomographic images will be recruited. In addition, Hospital staff members, who have been working within the Neurosurgical unit for at least 5 years will be interviewed.
The patients' data that will be collected will include gender, age at presentation, socioeconomic class of parents (or guardians), religion, referral source, presenting complaint with its duration, physical findings, ventricular diameter. The Pre-presentation symptoms interval (PPI) will be defined as the number of days between the onset of symptoms and first presentation at any type of healthcare service centre (including primary healthcare centre, secondary health institutions); Presentation Interval (PI)- Number of days from symptoms to presenting at Neurosurgical centre; Pre-diagnostic interval (PDI) will be defined as the interval in days between symptoms and completion of pre-operative investigations. Patient interval (PI) will be defined as the number of days from the onset of symptoms and patient's first contact with the Neurosurgical center. Hospital interval (HI)- number of days from completion of investigations to surgical intervention. The collected data will be analyzed according to qualitative conventional content analysis. Nvivo software version 13 and Statistical Product and Service Solutions (SPSS) version 23 will be used for data analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Age groups
- Child
- Study population
- Patients who present at the Lagos State University Teaching Hospital, Ikeja, Lagos for management of hydrocephalus
Key inclusion criteria (3 listed)
- All patients less than 5 years of age with HC confirmed with either magnetic resonance or computerized tomographic images
- Patients' parents' inclusion criteria will be parents (Guardians) of children with radiologically confirmed HC with either magnetic resonance or computerized tomographic images.
- Hospital staff members, who have been working within the Neurosurgical unit for at least 5 years.
Key exclusion criteria (2 listed)
- All patents not investigated or operated at our centre
- Patients older than 5 years
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 |
|---|---|---|
| HydrocephalusInterview | Other | – |
Primary outcome
Patient Presentation time in days
Time frame: 14 days
Time in days, from the onset of symptoms to the time the patient seeks medical advice.
Diagnostic delay in days
Time frame: 14 days
Time in days between the patient's presentation and the confirmation of the diagnosis, in days
Treatment delay in days
Time frame: 14 days
The duration (in days) between the diagnosis and initiation of treatment
3 secondary outcomes
Treatment outcome as perceived by parents/caregivers
Time frame: 4 weeks
Parents/caregivers satisfaction
Time frame: 4 weeks
Reason for delay in presentation, diagnosis and treatment
Time frame: 4 weeks
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 15 Dec 2025.
- Individual participant dataSharing planned: Yes. Anonymized data on request
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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.
Olufemi Idowu, FWACS, FACS principal investigator
Lagos State University Teaching Hospital, Ikeja, Lagos, Nigeria
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 Hydrocephalus in Children, run by Lagos State University at 1 site in Nigeria.
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 15 Dec 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 Nigeria. 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?
Patient Presentation time in days (time frame: 14 days). The study lists 3 primary outcomes in all. 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 15 Dec 2025.