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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04174430
Other study ID # IRB00010193
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2017
Est. completion date December 1, 2019

Study information

Verified date November 2019
Source Ho Chi Minh City University of Medicine and Pharmacy
Contact Dung Van Do, A. Professor
Phone +84396722467
Email htclan.y12e@ump.edu.vn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 51
Est. completion date December 1, 2019
Est. primary completion date December 1, 2019
Accepts healthy volunteers No
Gender All
Age group 2 Months to 12 Months
Eligibility 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 Design


Related Conditions & MeSH terms

  • Bronchiolitis
  • Epidemiological, Clinical, Paraclinical Characterictics of Severe Bronchiolitis

Intervention

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

Locations

Country Name City State
Vietnam Respiratory Ho Chi Minh City District 10

Sponsors (1)

Lead Sponsor Collaborator
Ho Chi Minh City University of Medicine and Pharmacy

Country where clinical trial is conducted

Vietnam, 

References & Publications (1)

Sáez-López E, Cristóvão P, Costa I, Pechirra P, Conde P, Guiomar R; Portuguese Laboratory Network for the Diagnosis of Influenza Infection. Epidemiology and genetic variability of respiratory syncytial virus in Portugal, 2014-2018. J Clin Virol. 2019 Oct — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with Severe bronchiolitis at the Children Hospital N01 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

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