Clinical and Paraclinical Characteristics of Severe Bronchiolitis in Children From 2 Months to 12 Months at the Children's Hospital 1 in Ho Chi Minh City - Vietnam

November 21, 2019 updated by: LAN HUYNH CHI, University of Medicine and Pharmacy at Ho Chi Minh City

Goal: The aim of this study is to determine the epidemiological, clinical, paraclinical characteristics and treatment of severe bronchiolitis at the Children Hospital N01 in 2001-2002.

Materials and method: in this cross-sectional study, specimens of 51 patients with severe bronchiolitis at the Children Hospital N01 from March, 1 st 2001 to February, 28th 2002 are described and analyzed.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

51

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

  • Vietnam
    • District 10
      • Ho Chi Minh City, District 10, Vietnam, 84

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

2 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

children younger from 2-12 months are diagnosed broncholitis in children hospital 1

Description

Inclusion Criteria:

  • children younger from 2-12 months present fever (usually ≤38.3ºC [101ºF]) ,cough, and respiratory distress (eg, increased respiratory rate, retractions, wheezing, crackles)
  • preceded by a one- to three-day history of upper respiratory tract symptoms (eg, nasal congestion and/or discharge) ]
  • Respiratory distress.

Exclusion Criteria:

  • refusal to give informed consent
  • mucus sample Barlett <=0

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
mild to moderate bronchiolitis
Bronchiolistis patients without Prematurity (gestational age ≤36 weeks), Low birth weight, Age less than 12 weeks, Chronic pulmonary disease, particularly bronchopulmonary dysplasia (also known as chronic lung disease), Anatomic defects of the airways, Hemodynamically significant congenital heart disease, Immunodeficiency and Neurologic disease
Biological: severe bronchiolitis
Prematurity (gestational age ≤36 weeks), Low birth weight, Age less than 12 weeks,Chronic pulmonary disease, particularly bronchopulmonary dysplasia (also known as chronic lung disease), Anatomic defects of the airways, Hemodynamically significant congenital heart disease, Immunodeficiency, Neurologic disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with Severe bronchiolitis at the Children Hospital N01
Time Frame: 2 years

Bronchiolitis in infants with:

  • Preterm birth : gestational age < 37 weeks

  • Respiratory failure:

    • Irritable condition
    • Breath rate > 50 per minute
    • Hypoxiemia: SpO2 < 94%
  • Poor feeding
  • Hemodynamically significant congenital heart disease (congennital heart failure, moderate to severe pulmonary hypertension or cyanotic heart disease)
2 years

Collaborators and Investigators

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

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Investigators

  • Study Director: Thinh Tan Nguyen, professor, HoChiMinh Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

August 1, 2017

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

November 16, 2019

First Submitted That Met QC Criteria

November 21, 2019

First Posted (Actual)

November 22, 2019

Study Record Updates

Last Update Posted (Actual)

November 25, 2019

Last Update Submitted That Met QC Criteria

November 21, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00010193

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

not yet

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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