NCT03131323

Brief Summary

Reactive airway diseases is a common respiratory diseases affecting 1-18% of the population in different countries. It carries a significant burden to children, their families, the healthcare system and the overall community.The purpose of the study is to delineate the prevalence of abnormal nasal finding in wheezy children and evaluate the role of the endoscopic examination of the nose in evaluation and management of a wheezy child.Patients and methods:The study will be conducted as a prospective case series including all children having chest wheezes, aged from two years to eighteen years, attending emergency unit of assuit university children hospital

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2017

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 27, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

April 27, 2017

Status Verified

April 1, 2017

Enrollment Period

1.1 years

First QC Date

April 23, 2017

Last Update Submit

April 26, 2017

Conditions

Keywords

delineate the prevalence of abnormal nasal finding in wheezy child

Outcome Measures

Primary Outcomes (1)

  • nasal findings in reactive airway diseases

    the prevalence of abnormal nasal finding in wheezy children

    one year

Interventions

. II- Equipments: * Flexible fiberopticnasopharyngoscope, 2.7 mm in diameter and fiberoptic light cable. * The camera: fitted with Three-CCD (Charged Couple Device) sensors. * A high resolution monitor. * A recording unit. III- Positioning:Infants and small children have to be held by a parent or an adult. Older children and adolescents usually tolerate office flexible nasopharyngoscopy once the procedure is explained. If office flexible nasopharyngoscopy failed because the child is not cooperative or if there is excessive secretions, general anesthesia may be required \[8\]. IV- Technique: Lubricant gel will be applied to the tip of the endoscope which will be now will be passed along the floor of the nose, between the inferior turbinate and the nasal septum, till it reaches the nasopharynx. Now the entire nose and the nasopharynx could be thoroughly examined and any abnormal findings could be detected and documented.

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

children aged from 2years to 18 years with recurrent wheezy ches

You may qualify if:

  • All children having chest wheezes, aged from two years to eighteen years, attending emergency unit of Assiut University Pediatric Hospital, during the period 1⁄6∕2017 to 1∕6⁄2018. They will be examined in Otolaryngology Department, Assiut University Hospital

You may not qualify if:

  • Refusal of endoscopic nasal examination by care givers.and patients with definite diagnosis of wheeze (bronchiolitis,pneumonia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveRespiratory Sounds

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

April 23, 2017

First Posted

April 27, 2017

Study Start

June 1, 2017

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

April 27, 2017

Record last verified: 2017-04