Electrolytes Disturbance in Infant | NCT07152951

Studies
Electrolytes Disturbance in Infant

NCT07152951

Sponsor

Assiut University

Status

Not yet recruiting

Last Update Posted

Sep 3, 2025Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Electrolyte Disturbance in Gastrointestinal Diseases

Interventions

Not provided

Countries

Not provided

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

Apr 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2026Estimated

Primary Completion Date

Jan 1, 2026Estimated

Completion Date

Jan 1, 2026Estimated

First Submitted Date

Aug 26, 2025

First Submission Date that Met QC Criteria

Aug 26, 2025

First Posted Date

Sep 3, 2025Actual

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

Aug 26, 2025

Last Update Posted Date

Sep 3, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Prevalence of electrolyte disturbances in infants and children with gastrointestinal diseases

Detailed Description

Prevalence of electrolyte disturbances in infants and children with gastrointestinal diseases

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

150Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
1-Determine prevalence and types of electrolyte disturbances in infants and children with gastrointestinal diseases		From 1 Jan 2025 to 1 Jan 2026

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients from one month till 4 years who will be admitted to Gastroenterology unit in (AUCH) and diagnosed with a gastrointestinal disease

Exclusion Criteria:

1-Neonates >1 month & those <4 years . 2-Patients with acute or chronic kidney diseases that alter electrolyte balance. 3-Patients with endocrine disorders affecting electrolyte balance (e.g adrenal insufficiency). 4-Use of medications that alter electrolyte balance (e.g diuretics, steroids). 5-Critically ill patients that electrolyte disturbance is due to non-gastrointestinal causes.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

4 Years

Standard Ages

Child

Study Population

All patients from one month till 4 years who will be admitted to Gastroenterology unit in (AUCH) and diagnosed with a gastrointestinal disease

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided