Critical Respiratory Diseases in Ex-preterm Infants in PICU

NCT ID: NCT04284891

Last Updated: 2022-05-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 202 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2021-05-30

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 30 Days
• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role: collaborator

Duke-NUS Graduate Medical School

OTHER

Sponsor Role: collaborator

National Children's Hospital, Vietnam

OTHER

Sponsor Role: lead

Responsible Party

Phuc Huu Phan

Deputy Director of Pediatric Intensive Care Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Phuc H Phan, MD

Role: PRINCIPAL_INVESTIGATOR

Vietnam National Children's Hospital

Jan Hau Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Duke-NUS Medical, Singapore

Locations

Vietnam National Children's Hospital

Hanoi, , Vietnam

Countries

Vietnam

Other Identifiers

2019-03

Identifier Type: -

Identifier Source: org_study_id