Foreign Body Swallows in Pediatrics

February 15, 2022 updated by: Bahaa Mohammed Refaie

Foreign Body Swallows With Airway Affection in Pediatrics

Foreign Body Ingestion (FBI) is a common clinical emergency in children. Most FBs smoothly pass through the digestive tract without complications; nevertheless, some FBs can cause severe morbidity and mortality. The current work aimed at evaluating how FBI can cause respiratory distress and stridor as well as their severity according to age, gender, lodgment site, and type of the object. Factors influencing morbidity and mortality among studied patients will be deliberated as well.

Study Overview

Status

Completed

Detailed Description

Background: Foreign Body Ingestion (FBI) is a common clinical emergency in children. Most FBs smoothly pass through the digestive tract without complications; nevertheless, some FBs can cause severe morbidity and mortality. The current work aimed at evaluating how the FBI can cause respiratory distress and stridor as well as their severity according to age, gender, lodgment site, and type of the object. Factors influencing morbidity and mortality among studied patients will be deliberated as well.

Methods: It is a hospital-based descriptive study where all children between birth and 16 years of age who were admitted from January 1 st, 2018 to December, 31th 2021 for FBs removal were analyzed. All cases were subjected to complete history taking, physical, radiological, and bronchoscopic examination.

Study Type

Observational

Enrollment (Actual)

14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Sohag, Egypt, 82524
        • Sohag faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

children between birth and 16 years of age

Description

Inclusion Criteria:

  • children between birth and 16 years of age FBs removal
  • history suggestive of foreign body swallow

Exclusion criteria:

- none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory distress
Time Frame: 24 hour after presentation
stridor due to foreign body swallow
24 hour after presentation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

October 1, 2021

Study Registration Dates

First Submitted

November 9, 2021

First Submitted That Met QC Criteria

February 15, 2022

First Posted (Actual)

February 23, 2022

Study Record Updates

Last Update Posted (Actual)

February 23, 2022

Last Update Submitted That Met QC Criteria

February 15, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023 (GRAMMY Museum Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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