Critical Respiratory Diseases in Ex-preterm Infants in PICU

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04284891
• Other study ID #: 2019-03
• Status: Completed
• Start date: November 1, 2019
• Est. completion date: May 30, 2021

Study information

• Verified date: April 2022
• Source: National Children's Hospital, Vietnam
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: May 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

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:

• Nil

Related Conditions & MeSH terms

• Infant, Premature, Diseases
• Premature Birth
• Respiration Disorders
• Respiratory Disease
• Respiratory Failure
• Respiratory Insufficiency
• Respiratory Tract Diseases

Locations

Country	Name	City	State
Vietnam	Vietnam National Children's Hospital	Hanoi

Sponsors (3)

Lead Sponsor	Collaborator
National Children's Hospital, Vietnam	Duke-NUS Graduate Medical School, KK Women's and Children's Hospital

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of ex-premature infants aged < 2 years admitted to Pediatric Intensive Care Unit (PICU)	The percentage of ex-premature patients to the total number of patients aged = 2 years age admitted to PICU over a defined period	Through study completion, an average of 1 year
Primary	Percentage of ex- premature infants aged < 2 years admitted to PICU with critical respiratory diseases.	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	Through study completion, an average of 1 year
Secondary	Percentage of identified pathogens of critical respiratory diseases among study participants	Proportion of identified etiologies of critical respiratory diseases among participants will be reported	Up to 60 days
Secondary	Number of participants with all-cause mortality	The number of participants who died due to any cause while on the treatment will be assessed	Up to 60 days
Secondary	Time from start to end of mechanical ventilation	Time from start to end of mechanical ventilation will be measure	Up to 60 days
Secondary	Time from pediatric intensive care unit (PICU) admission to PICU discharge	The duration for how long the participant remained in the PICU that is the time from PICU admission to PICU discharge will be measured	Up to 60 days
Secondary	Percentage of participants receiving mechanical ventilation support	Percentage of participants receiving mechanical ventilation support will be reported. Mechanical ventilation support include invasive and non-invasive mechanical ventilation.	Up to 60 days
Secondary	Percentage of participants receiving diagnostic imaging services	Percentage of participants receiving diagnostic imaging services will be reported. Diagnostic imaging services include chest x-ray, chest computer tomography, cardiac ultrasound.	Up to 60 days
Secondary	Percentage of participants receiving microbiological diagnostics	Percentage of participants receiving microbiological diagnostics will be reported. Microbiological diagnostics include bacterial cultures and polymerase chain reaction (PCR) tests	Up to 60 days