Barriers to Patients' Early Presentation, Diagnosis and T... | NCT05796713

Studies
Barriers to Patients' Early Presentation, Diagnosis and Treatment in Childhood Hydrocephalus

NCT05796713

Sponsor

Lagos State University

Status

Completed

Last Update Posted

Dec 15, 2025Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Hydrocephalus in Children

Interventions

Hydrocephalus

Countries

Nigeria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2023Actual

Primary Completion Date

Jan 27, 2024Actual

Completion Date

Jan 27, 2024Actual

First Submitted Date

Mar 7, 2023

First Submission Date that Met QC Criteria

Apr 1, 2023

First Posted Date

Apr 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2025

Last Update Posted Date

Dec 15, 2025Actual

Name	Class
Hydrocephalus Association	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Name	Type	Description	Arm Group Labels	Other Names
Hydrocephalus	Other	Interview

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient Presentation time in days	Time in days, from the onset of symptoms to the time the patient seeks medical advice.	14 days
Diagnostic delay in days	Time in days between the patient's presentation and the confirmation of the diagnosis, in days	14 days
Treatment delay in days	The duration (in days) between the diagnosis and initiation of treatment	14 days

Secondary Outcomes

Measure	Description	Time Frame
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)	4 weeks
Parents/caregivers satisfaction

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

All patents not investigated or operated at our centre
Patients older than 5 years

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

5 Years

Standard Ages

Child

Study Population

Patients who present at the Lagos State University Teaching Hospital, Ikeja, Lagos for management of hydrocephalus

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Olufemi Idowu, FWACS, FACS	Lagos State University Teaching Hospital, Ikeja, Lagos, Nigeria	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lagos State University Teaching Hospital		Ikeja	Lagos	20001	Nigeria

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Anonymized data on request

Types

Study Protocol

Time Frame

Jan 2024 till Jan 2025

Access Criteria

via email

URL

Not provided