NCT05253027

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 9, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 23, 2022

Completed
Last Updated

February 23, 2022

Status Verified

February 1, 2022

Enrollment Period

3 years

First QC Date

November 9, 2021

Last Update Submit

February 15, 2022

Conditions

Foreign Body in Oropharynx

Keywords

Foreign BodiesChildRespiratory distressHypopharynxEsophagoscopy

Outcome Measures

Primary Outcomes (1)

  • Respiratory distress

    stridor due to foreign body swallow

    24 hour after presentation

Eligibility Criteria

Age1 Day - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

children between birth and 16 years of age

You may qualify if:

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

You may not qualify if:

  • \- none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag faculty of medicine

Sohag, 82524, Egypt

Location

MeSH Terms

Conditions

Foreign BodiesDyspnea

Condition Hierarchy (Ancestors)

Wounds and InjuriesRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
lecturer of anesthesia and ICu

Study Record Dates

First Submitted

November 9, 2021

First Posted

February 23, 2022

Study Start

January 1, 2018

Primary Completion

December 31, 2020

Study Completion

October 1, 2021

Last Updated

February 23, 2022

Record last verified: 2022-02

Locations

EG(1)