Critical Respiratory Diseases in Ex-preterm Infants in PICU

Completed

• Conditions: Premature Birth; Infant, Premature, Diseases; Respiratory Disease; Respiratory Failure

• Registration Number: NCT04284891
• Lead Sponsor: National Children's Hospital, Vietnam

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-21
• Study Start: 2019-11-01
• Study First Submitted QC: 2020-02-24
• Study First Posted: 2020-02-26
• Primary Completion: 2021-05-30
• Study Completion: 2021-05-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-29
• Last Update Posted: 2022-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of ex-premature infants aged < 2 years admitted to Pediatric Intensive Care Unit (PICU)	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.	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 Outcome Measures

Name	Time	Method
Percentage of identified pathogens of critical respiratory diseases among study participants	Up to 60 days	Proportion of identified etiologies of critical respiratory diseases among participants will be reported
Number of participants with all-cause mortality	Up to 60 days	The number of participants who died due to any cause while on the treatment will be assessed
Percentage of participants receiving diagnostic imaging services	Up to 60 days	Percentage of participants receiving diagnostic imaging services will be reported. Diagnostic imaging services include chest x-ray, chest computer tomography, cardiac ultrasound.
Time from pediatric intensive care unit (PICU) admission to PICU discharge	Up to 60 days	The duration for how long the participant remained in the PICU that is the time from PICU admission to PICU discharge will be measured
Percentage of participants receiving mechanical ventilation support	Up to 60 days	Percentage of participants receiving mechanical ventilation support will be reported. Mechanical ventilation support include invasive and non-invasive mechanical ventilation.
Time from start to end of mechanical ventilation	Up to 60 days	Time from start to end of mechanical ventilation will be measure
Percentage of participants receiving microbiological diagnostics	Up to 60 days	Percentage of participants receiving microbiological diagnostics will be reported. Microbiological diagnostics include bacterial cultures and polymerase chain reaction (PCR) tests

Trial Locations

Locations (1)

Vietnam National Children's Hospital; 🇻🇳 Hanoi, Vietnam