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CompletedNCT05253027Updated Feb 23, 2022

Foreign Body Swallows in Pediatrics

An observational study in Foreign Body in Oropharynx, sponsored by Bahaa Mohammed Refaie. Completed at 1 site in Egypt. Open to participants aged 1 Day to 16 Years. Per ClinicalTrials.gov, last updated 2022-02-23.

Sponsored by Bahaa Mohammed Refaie · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
14
Ages
1 Day to 16 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Foreign Body in Oropharynx

Keywords

  • Foreign Bodies
  • Child
  • Respiratory distress
  • Hypopharynx
  • Esophagoscopy
03

In context

Foreign Bodies

29 studies on the registry are indexed under Foreign Bodies; 8 are open to participants now.

This study's enrollment of 14 is below the median of 100 across 19 observational studies indexed under Foreign Bodies.

Browse Foreign Bodies studies →

Lead sponsor

Bahaa Mohammed Refaie is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

children between birth and 16 years of age

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion criteria:

  • none
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
14 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Respiratory distress

    stridor due to foreign body swallow

    Time frame: 24 hour after presentation

07

Study locations

1 site
  • Sohag faculty of medicine
    Sohag, 82524, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2018 to primary completion in Dec 2020, 35 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 9, 2021
First posted
Feb 23, 2022
StartActual
Jan 1, 2018
Primary completionActual
Dec 31, 2020
CompletionActual
Oct 1, 2021
Last update
Feb 23, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05253027
Lead sponsor
Bahaa Mohammed Refaie
Responsible party
Bahaa Mohammed Refaie (lecturer of anesthesia and ICu, Sohag University) — Sponsor-investigator
First posted
Feb 23, 2022
Start date
Jan 1, 2018
Primary completion
Dec 31, 2020
Completion
Oct 1, 2021
Last update
Feb 23, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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