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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

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ClinicalTrials.gov Identifier: NCT04174430
Recruitment Status : Recruiting
First Posted : November 22, 2019
Last Update Posted : November 25, 2019
Sponsor:
Information provided by (Responsible Party):
LAN HUYNH CHI, Ho Chi Minh City University of Medicine and Pharmacy

Brief Summary:

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.


Condition or disease Intervention/treatment
Epidemiological, Clinical, Paraclinical Characterictics of Severe Bronchiolitis Biological: severe bronchiolitis

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Study Type : Observational
Estimated Enrollment : 51 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: 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
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   2 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
children younger from 2-12 months are diagnosed broncholitis in children hospital 1
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04174430


Contacts
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Contact: Dung Van Do, A. Professor +84396722467 htclan.y12e@ump.edu.vn

Locations
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Vietnam
Respiratory Recruiting
Ho Chi Minh City, District 10, Vietnam, 84
Contact: Dung Van Do, a professor    84336729444    nguyenthikimoanh0294@gmail.com   
Sponsors and Collaborators
Ho Chi Minh City University of Medicine and Pharmacy
Investigators
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Study Director: Thinh Tan Nguyen, professor HoChiMinh Medical University

Additional Information:
Publications of Results:
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Responsible Party: LAN HUYNH CHI, Pediatric Resident, Clinical Physician, Respiratory Department, Children Hospital N01, Ho Chi Minh City University of Medicine and Pharmacy
ClinicalTrials.gov Identifier: NCT04174430    
Other Study ID Numbers: IRB00010193
First Posted: November 22, 2019    Key Record Dates
Last Update Posted: November 25, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: not yet

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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
Additional relevant MeSH terms:
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Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections