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临床试验/NCT05084976
NCT05084976已完成不适用

Parental Perception of COVID-19 Vaccine in Pediatric Patients With Tracheostomy and Ventilator Dependence

Northwell Health1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年9月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Percentage of pediatric patient getting COVID 19 vaccine

研究概览

简要总结

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.

详细描述

Vaccinating the population is the next step in combating COVID 19 pandemic however there continues to be vaccine hesitancy. Vaccine hesitancy is the indecision of consenting to vaccination (Dosanjh, 2021) and is not a new phenomenon. The most recent example is the reemergence of measles in the United States prior to the COVID 19 pandemic. Anti-vaccine groups have spread messages of conspiracy theories, myths and misperceptions, questions about the speed of vaccine development and long term side effects in the media which also attributes to COVID-19 vaccine hesitancy (Khubcandani et al, 2021).

Children infected with COVID 19 typically have mild symptoms of the disease. Risk factors associated with severe disease are neonatal age group, male gender, lower respiratory tract disease and pre-existing medical conditions. Children who use chronic home mechanical ventilation are considered a high-risk group for developing severe COVID 19 infection (Vasconcello-Castillo et al., 2020). These children have various diagnoses and pathologies such as neuromuscular disease, sleep disorders and chronic lung disease. These patients require continuous use of ventilatory support in the home and are at high risk for respiratory infections and mortality. Most of these patients need advanced nursing care and special respiratory equipment to prevent hospitalization such as manual chest physiotherapy, mechanical ex-sufflator device, chest vest device and increased ventilator support.

Recently the FDA approved of Pfizer's COVID 19 vaccine in ages 12 and older. It is anticipated that by fall 2021 the Pfizer COVID 19 vaccine will be approved by the FDA for children ages 2 and older. Vaccinating children will help decrease transmission of COVID 19, contribute to community immunity and allow kids go back to camps this summer and back to in-person school more safely.

Since the chronic home mechanical ventilation population is at risk for developing severe COVID 19 disease, the investigator would hypothesize that most parents are ready and willing to vaccinate their children. The purpose of this study is to evaluate the parental perception of COVID 19 vaccine in pediatric patients with "technology dependence" and identify the barriers to vaccination.

After surveys are collected and barriers are identified, vaccine counseling will be provided by a provider (nurse practitioner or physician). Vaccine safety, efficacy, side effects will be reviewed with the parents.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
— 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Other caretakers such as grandparents, aunts, uncles

结局指标

主要结局

Percentage of pediatric patient getting COVID 19 vaccine

时间窗: 6 months after initial survey

次要结局

  • Percentage of other adults in household getting COVID 19 vaccine(6 months after initial survey)
  • Percentage of mothers getting COVID 19 vaccine(6 months after initial survey)
  • Percentage of fathers getting COVID 19 vaccine(6 months after initial survey)
  • Percentage of other eligible children in household getting COVID 19 vaccine(6 months after initial survey)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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