Mechanical Ventilation Complication Clinical Trial
Official title:
Parental Perception of COVID-19 Vaccine in Pediatric Patients With Tracheostomy and Ventilator Dependence
NCT number | NCT05084976 |
Other study ID # | 21-0822 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 23, 2021 |
Est. completion date | March 31, 2022 |
Verified date | July 2022 |
Source | Northwell Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study involves conducting a telephonic or in person survey regarding parental perception and attitudes about vaccinating the respective "technology dependent" child with the COVID 19 vaccination. "Technology dependent" includes tracheostomy dependence, artificial ventilator dependence and non invasive mechanical ventilation dependence. This population is vulnerable since most patients have underlying lung disease, chronic respiratory failure and require respiratory equipment to assist with breathing. "Technology dependent" patients are particularly vulnerable to respiratory infections and are considered high risk for developing severe COVID 19 illness. Despite this population's high risk for morbidity and mortality from respiratory viral infections, the investigator hypothesize that 50% of the parents are still vaccine hesitant.
Status | Completed |
Enrollment | 60 |
Est. completion date | March 31, 2022 |
Est. primary completion date | March 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 21 Years |
Eligibility | Inclusion Criteria: - Mother or father of child will be interviewed - Pediatric patient (age 0-21) - "Technology dependent" with one or more of the following: tracheostomy, ventilator use, non-invasive mechanical ventilator use (BiPAP, CPAP, Airvo), diaphragmatic pacing, oxygen Exclusion Criteria: - Other caretakers such as grandparents, aunts, uncles |
Country | Name | City | State |
---|---|---|---|
United States | Northwell Health Physician Partners | Lake Success | New York |
Lead Sponsor | Collaborator |
---|---|
Northwell Health |
United States,
Dosanjh A. Pediatric Vaccine Hesitancy and the Utilization of Antibody Measurements: A Novel Strategy with Implications for COVID 19. J Asthma Allergy. 2021 Apr 23;14:427-431. doi: 10.2147/JAA.S303309. eCollection 2021. — View Citation
Khubchandani J, Sharma S, Price JH, Wiblishauser MJ, Sharma M, Webb FJ. COVID-19 Vaccination Hesitancy in the United States: A Rapid National Assessment. J Community Health. 2021 Apr;46(2):270-277. doi: 10.1007/s10900-020-00958-x. Epub 2021 Jan 3. — View Citation
McAteer J, Yildirim I, Chahroudi A. The VACCINES Act: Deciphering Vaccine Hesitancy in the Time of COVID-19. Clin Infect Dis. 2020 Jul 28;71(15):703-705. doi: 10.1093/cid/ciaa433. — View Citation
Vasconcello-Castillo L, Torres-Castro R, Vera-Uribe R, Paiva R. COVID-19: Precautions with children in home mechanical ventilation. Pediatr Res. 2020 Oct;88(4):520-521. doi: 10.1038/s41390-020-1047-7. Epub 2020 Jul 2. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of pediatric patient getting COVID 19 vaccine | 6 months after initial survey | ||
Secondary | Percentage of mothers getting COVID 19 vaccine | 6 months after initial survey | ||
Secondary | Percentage of fathers getting COVID 19 vaccine | 6 months after initial survey | ||
Secondary | Percentage of other adults in household getting COVID 19 vaccine | 6 months after initial survey | ||
Secondary | Percentage of other eligible children in household getting COVID 19 vaccine | 6 months after initial survey |
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