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Clinical Trials/NCT04284891
NCT04284891
Completed
Not Applicable

The Epidemiology of Critical Respiratory Diseases in Ex-preterm Infants Admitted to the Pediatric Intensive Care in Vietnam

National Children's Hospital, Vietnam1 site in 1 country202 target enrollmentNovember 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infant, Premature, Diseases
Sponsor
National Children's Hospital, Vietnam
Enrollment
202
Locations
1
Primary Endpoint
Percentage of ex-premature infants aged < 2 years admitted to Pediatric Intensive Care Unit (PICU)
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Premature birth is the leading cause of death in children younger than 5 years old worldwide, especially in low- and middle-income countries. Premature infants who survive are at greater risk of a range of short-term and long-term health consequences. Common long-term health morbidities among children who are born prematurely include cerebral palsy, infections (particularly respiratory infections), bronchopulmonary dysplasia, feeding difficulties, hypoxic-ischemic encephalopathy, visual and hearing problems. Re-hospitalization occurs frequently during first few years of life among ex-premature infants with respiratory illness. This leads to increased financial burden for health care system and families. The impact of prematurity on the health care system, especially on pediatric intensive care units (PICUs) has mainly been evaluated in high income countries. Little is known about long term health outcomes of ex-premature infants and their impact on the cost to health care system in low- and middle-income countries. This pilot, single institution, observational study aims to determine the prevalence, course of the diseases, and outcomes of ex-premature infants with respiratory illnesses who are admitted to a PICU of a tertiary children's hospital in Vietnam. Investigators will determine the epidemiology of respiratory illness, and the resource utilization for these children in the PICU. To achieve these aims, the investigators will prospectively screen and recruit all children aged less than 2 years old admitted to the PICU with respiratory illness/failure and collect pertinent clinical data. The study participants will be follow-up until PICU discharge.

Registry
clinicaltrials.gov
Start Date
November 1, 2019
End Date
May 30, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
National Children's Hospital, Vietnam
Responsible Party
Principal Investigator
Principal Investigator

Phuc Huu Phan

Deputy Director of Pediatric Intensive Care Unit

National Children's Hospital, Vietnam

Eligibility Criteria

Inclusion Criteria

  • All patients aged ≤ 2 year olds with respiratory diseases admitted to pediatric intensive care unit of Vietnam National Children's Hospital

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Percentage of ex-premature infants aged < 2 years admitted to Pediatric Intensive Care Unit (PICU)

Time Frame: Through study completion, an average of 1 year

The percentage of ex-premature patients to the total number of patients aged ≤ 2 years age admitted to PICU over a defined period

Percentage of ex- premature infants aged < 2 years admitted to PICU with critical respiratory diseases.

Time Frame: Through study completion, an average of 1 year

The percentage of ex-premature patients to the total number of patients aged ≤ 2 years age with respiratory illness admitted to PICU over a defined period

Secondary Outcomes

  • Percentage of identified pathogens of critical respiratory diseases among study participants(Up to 60 days)
  • Number of participants with all-cause mortality(Up to 60 days)
  • Percentage of participants receiving diagnostic imaging services(Up to 60 days)
  • Time from pediatric intensive care unit (PICU) admission to PICU discharge(Up to 60 days)
  • Percentage of participants receiving mechanical ventilation support(Up to 60 days)
  • Time from start to end of mechanical ventilation(Up to 60 days)
  • Percentage of participants receiving microbiological diagnostics(Up to 60 days)

Study Sites (1)

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