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Completed

NCT Number: NCT04284891

Critical Respiratory Diseases in Ex-preterm Infants in PICU

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Percentage of ex-premature infants aged < 2 years admitted to Pediatric Intensive Care Unit (PICU)

    Time frame: 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

  2. Percentage of ex- premature infants aged < 2 years admitted to PICU with critical respiratory diseases.

    Time frame: 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 outcomes

  1. Percentage of identified pathogens of critical respiratory diseases among study participants

    Time frame: Up to 60 days

    Proportion of identified etiologies of critical respiratory diseases among participants will be reported

  2. Number of participants with all-cause mortality

    Time frame: Up to 60 days

    The number of participants who died due to any cause while on the treatment will be assessed

  3. Time from start to end of mechanical ventilation

    Time frame: Up to 60 days

    Time from start to end of mechanical ventilation will be measure

  4. Time from pediatric intensive care unit (PICU) admission to PICU discharge

    Time frame: 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

  5. Percentage of participants receiving mechanical ventilation support

    Time frame: Up to 60 days

    Percentage of participants receiving mechanical ventilation support will be reported. Mechanical ventilation support include invasive and non-invasive mechanical ventilation.

  6. Percentage of participants receiving diagnostic imaging services

    Time frame: 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.

  7. Percentage of participants receiving microbiological diagnostics

    Time frame: Up to 60 days

    Percentage of participants receiving microbiological diagnostics will be reported. Microbiological diagnostics include bacterial cultures and polymerase chain reaction (PCR) tests

Sponsors and collaborators

Lead sponsor

National Children's Hospital, Vietnam

Other

Collaborators

  • Duke-NUS Graduate Medical School
  • KK Women's and Children's Hospital

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 26, 2020
Registry last updated
May 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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