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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04284891
Enrollment
202
Registered
2020-02-26
Start date
2019-11-01
Completion date
2021-05-30
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

None listed

Sponsors

KK Women's and Children's Hospital
CollaboratorOTHER_GOV
Duke-NUS Graduate Medical School
CollaboratorOTHER
National Children's Hospital, Vietnam
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Days to 2 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of ex-premature infants aged < 2 years admitted to Pediatric Intensive Care Unit (PICU)Through study completion, an average of 1 yearThe 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 yearThe 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

MeasureTime frameDescription
Time from start to end of mechanical ventilationUp to 60 daysTime from start to end of mechanical ventilation will be measure
Time from pediatric intensive care unit (PICU) admission to PICU dischargeUp to 60 daysThe 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 identified pathogens of critical respiratory diseases among study participantsUp to 60 daysProportion of identified etiologies of critical respiratory diseases among participants will be reported
Percentage of participants receiving diagnostic imaging servicesUp to 60 daysPercentage of participants receiving diagnostic imaging services will be reported. Diagnostic imaging services include chest x-ray, chest computer tomography, cardiac ultrasound.
Percentage of participants receiving microbiological diagnosticsUp to 60 daysPercentage of participants receiving microbiological diagnostics will be reported. Microbiological diagnostics include bacterial cultures and polymerase chain reaction (PCR) tests
Percentage of participants receiving mechanical ventilation supportUp to 60 daysPercentage of participants receiving mechanical ventilation support will be reported. Mechanical ventilation support include invasive and non-invasive mechanical ventilation.
Number of participants with all-cause mortalityUp to 60 daysThe number of participants who died due to any cause while on the treatment will be assessed

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026