Clinical trial NCT04284891: Critical Respiratory Diseases in Ex-preterm Infants in PICU
Official title: The Epidemiology of Critical Respiratory Diseases in Ex-preterm Infants Admitted to the Pediatric Intensive Care in Vietnam
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant, Premature, Diseases
Respiratory Disease
Respiratory Failure
Premature Birth
Keywords: Respiratory Diseases, ex-prematurity
Respiratory Failure
Pediatric Intensive Care
Lead sponsor: National Children's Hospital, Vietnam
Sponsor class: OTHER
Collaborators: name: KK Women's and Children's Hospital
name: Duke-NUS Graduate Medical School
First posted: 2020-02-26
Enrollment: 202
Sex: ALL
Minimum age (years): 30
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients aged ≤ 2 year olds with respiratory diseases

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of ex-premature infants aged < 2 years admitted to Pediatric Intensive Care Unit (PICU)
timeFrame: Through study completion, an average of 1 year
measure: Percentage of ex- premature infants aged < 2 years admitted to PICU with critical respiratory diseases.
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Percentage of identified pathogens of critical respiratory diseases among study participants
timeFrame: Up to 60 days
measure: Number of participants with all-cause mortality
timeFrame: Up to 60 days
measure: Time from start to end of mechanical ventilation
timeFrame: Up to 60 days
measure: Time from pediatric intensive care unit (PICU) admission to PICU discharge
timeFrame: Up to 60 days
measure: Percentage of participants receiving mechanical ventilation support
timeFrame: Up to 60 days
measure: Percentage of participants receiving diagnostic imaging services
timeFrame: Up to 60 days
measure: Percentage of participants receiving microbiological diagnostics
timeFrame: Up to 60 days
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Vietnam National Children's Hospital
Study officials:
affiliation: Vietnam National Children's Hospital
name: Phuc H Phan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke-NUS Medical, Singapore
name: Jan Hau Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: