Critical Respiratory Diseases in Ex-preterm Infants in PICU

NCT04284891 | Completed

• 1 other identifier: 2019-03
• Study Type: observational
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant, Premature, Diseases; Respiratory Disease; Respiratory Failure; Premature Birth

Keywords

Respiratory Diseases, ex-prematurity; Respiratory Failure; Pediatric Intensive Care

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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

• Time from start to end of mechanical ventilation

  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

Eligibility Criteria

• Age: 30 Days - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All patients aged ≤ 2 year olds with respiratory diseases

You may qualify if:

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

You may not qualify if:

• Nil

Sponsors & Collaborators

• National Children's Hospital, Vietnam: lead
• KK Women's and Children's Hospital: collaborator
• Duke-NUS Graduate Medical School: collaborator

Study Sites (1)

Vietnam National Children's Hospital

Hanoi, Vietnam

Location

MeSH Terms

Conditions

Infant, Premature, Diseases; Respiration Disorders; Respiratory Insufficiency; Premature Birth; Respiratory Tract Diseases

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Phuc H Phan, MD

  Vietnam National Children's Hospital

  PRINCIPAL INVESTIGATOR

• Jan Hau Lee, MD

  Duke-NUS Medical, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of Pediatric Intensive Care Unit

Study Record Dates

• First Submitted: September 21, 2019
• First Posted: February 26, 2020
• Study Start: November 1, 2019
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2021
• Last Updated: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)