Critical Respiratory Diseases in Ex-preterm Infants in PICU

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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 202

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam
    • Vietnam National Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients aged ≤ 2 year olds with respiratory diseases

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Time from start to end of mechanical ventilation	Time from start to end of mechanical ventilation will be measure	Up to 60 days
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
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
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
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

Collaborators and Investigators

• Sponsor: National Children's Hospital, Vietnam
• Collaborators: KK Women's and Children's Hospital; Duke-NUS Graduate Medical School
• Investigators: Principal Investigator: Phuc H Phan, MD, Vietnam National Children's Hospital; Principal Investigator: Jan Hau Lee, MD, Duke-NUS Medical, Singapore

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): May 30, 2021
• Study Completion (Actual): May 30, 2021

Study Registration Dates

• First Submitted: September 21, 2019
• First Submitted That Met QC Criteria: February 24, 2020
• First Posted (Actual): February 26, 2020

Study Record Updates

• Last Update Posted (Actual): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 29, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Respiratory Failure; Respiratory Diseases, ex-prematurity; Pediatric Intensive Care
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Infant, Premature, Diseases; Respiratory Insufficiency; Premature Birth; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: 2019-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No