NCT04654832

Brief Summary

IVC Index in patient with Diarrhea and Dehydration And How It affects its management.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2020

Completed
Last Updated

December 4, 2020

Status Verified

December 1, 2020

Enrollment Period

3 months

First QC Date

October 19, 2020

Last Update Submit

December 3, 2020

Conditions

Keywords

IVC Index

Outcome Measures

Primary Outcomes (1)

  • (IVC Index in patient with Diarrhea and Dehydration and how it affects it's management.)

    Assessment of dehydration by ivc index and bcmanagement according to this index

    IVC Index in patient with Diarrhea and Dehydration And How It affects its management21.(13). it expect it expected to be done from 1 October2020 till 29 December2021.(13)

Eligibility Criteria

Age1 Month - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

\*Sample size: According to the G\*Power 3 software (Faul et al., 2007); the calculated minimum sample was 57 patient with dehydration needed to detect an effect size of 0.5 in the percentage of weight change after rehydration (12), with an error probability of 0.05 and 95 % power on a two-tailed test, it expected to be done from 1 October2020 till 29 December2021.(13)

You may qualify if:

  • Patients under 5years old who Presented with acute diarrhea and clinical evidence of significant (Moderate and severe) dehydration and sepsis based on blood picture ,high grade fever and CRP
  • Patients under 5 years old with dehydration and non septic condition.
  • Patients under 5years old have cardiomyopathy previously diagnosed.

You may not qualify if:

  • Patients receiving oral rehydration solution only .
  • chronic medical conditions, bronchopulmonary dysplasia and renal and liver diseases.
  • Children with acute blood loss were also excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reham

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Diarrhea, Infantile

Condition Hierarchy (Ancestors)

DiarrheaSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Elsayed Khalil Abd elkarem, Professor

    Assiut University

    STUDY DIRECTOR
  • Duaa Mohamad raafat, Assistant

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Reham RR Refaat, Master

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

October 19, 2020

First Posted

December 4, 2020

Study Start

October 1, 2020

Primary Completion

December 29, 2020

Study Completion

December 29, 2020

Last Updated

December 4, 2020

Record last verified: 2020-12

Locations