Infant, Premature, DiseasesNCT04284891
Critical Respiratory Diseases in Ex-preterm Infants in PICU
An observational study of Infant, Premature, Diseases and Respiratory Disease, run by National Children's Hospital, Vietnam at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 days to 2 years
- Conditions the study is for
- Infant, Premature, Diseases, Respiratory Disease, Respiratory Failure
- How many people
- 202 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Nov 2019to 30 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 days to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: All patients aged ≤ 2 year olds with respiratory diseases
Who may be able to join
- All patients aged ≤ 2 year olds with respiratory diseases admitted to pediatric intensive care unit of Vietnam National Children's Hospital
Who cannot join
- Nil
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Keywords
- Respiratory Diseases, ex-prematurity, Respiratory Failure, Pediatric Intensive Care
- Medical subject headings
- Infant, Premature, Diseases, Respiration Disorders, Respiratory Insufficiency, Premature Birth, Respiratory Tract Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Through study completion, an average of 1 year
Secondary outcomes (7)
Percentage of identified pathogens of critical respiratory diseases among study participants
Proportion of identified etiologies of critical respiratory diseases among participants will be reported
Measured: 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
Measured: Up to 60 days
Time from start to end of mechanical ventilation
Time from start to end of mechanical ventilation will be measure
Measured: 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
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.
Measured: 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.
Measured: 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
Measured: Up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start1 Nov 2019
- Primary completion30 May 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Premature, DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Children's Hospital, Vietnam
- Sponsor type
- University, hospital or other
- Collaborators
- KK Women's and Children's Hospital, Duke-NUS Graduate Medical School
- Responsible party
- Principal investigator, Phuc Huu Phan, National Children's Hospital, Vietnam
- Investigators
- Phuc H Phan, MD, Principal investigator, National Children's Hospital, VietnamJan Hau Lee, MD, Principal investigator, Duke-NUS Medical, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284891
- Sponsor's protocol ID
- 2019-03
- Status last verified
- Apr 2022
- First submitted
- 21 Sep 2019
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Epidemiology of Critical Respiratory Diseases in Ex-preterm Infants Admitted to the Pediatric Intensive Care in Vietnam
- ClinicalTrials.gov ID
- NCT04284891
- Acronym / sponsor ID
- 2019-03
- Keywords
- Respiratory Diseases, ex-prematurity, Respiratory Failure, Pediatric Intensive Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- National Children's Hospital, VietnamUniversity, hospital or other
- Collaborators
- KK Women's and Children's Hospital, Duke-NUS Graduate Medical School
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 days to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All patients aged ≤ 2 year olds with respiratory diseases
Key inclusion criteria (1 listed)
- All patients aged ≤ 2 year olds with respiratory diseases admitted to pediatric intensive care unit of Vietnam National Children's Hospital
Key exclusion criteria (1 listed)
- Nil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
7 secondary outcomes
Percentage of identified pathogens of critical respiratory diseases among study participants
Time frame: Up to 60 days
Number of participants with all-cause mortality
Time frame: Up to 60 days
Time from start to end of mechanical ventilation
Time frame: Up to 60 days
Time from pediatric intensive care unit (PICU) admission to PICU discharge
Time frame: Up to 60 days
Percentage of participants receiving mechanical ventilation support
Time frame: Up to 60 days
Percentage of participants receiving diagnostic imaging services
Time frame: Up to 60 days
Percentage of participants receiving microbiological diagnostics
Time frame: Up to 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phuc H Phan, MD principal investigator
National Children's Hospital, Vietnam
Jan Hau Lee, MD principal investigator
Duke-NUS Medical, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, Premature, Diseases and Respiratory Disease, run by National Children's Hospital, Vietnam at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.