Mattel Children's Hospital at UCLA
Pertussis Study - Objective and Study Design
__________________________________________________
Objective:
The overall purpose of this multicenter prospective cohort study is to describe
the societal burden of severe pertussis in the US pediatric population
from clinical and health outcome perspectives.
Children < 18 years of age
with pertussis who require hospitalization in the pediatric intensive care unit
(PICU) during their illness will be studied (critical pertussis).
The specific
aims of this study are:
Specific Aim 1. Characterize children’s presentation and acute course of
critical pertussis during the PICU admission. Assess severity of illness
(Pediatric Risk of Mortality (PRISM III)) at the time of PICU admission,
provision of selected modalities of therapy, lengths of ventilatory
support, duration of PICU stay, and disposition, including neurologic
status, at the time of discharge.
Specific Aim 2. Assess reported health status and family impact in children
following discharge from the PICU.
Specific Aim 3. Assess developmental sequelae and quality of life 12 months
after discharge from the PICU, for infants who were admitted to the
PICU at < 12 months of gestational age, using standardized tools.
Specific Aim 4. Assess risk factors associated with developmental sequelae
in children who were admitted to the PICU at < 12 months of
gestational age.
Eligibility:
Eligible subjects for this study are those who meet one of the enrollment case
definitions for pertussis:
-
Childen < 18 years of age, and require hospitalization in a pediatric intensive
care unit (PICU) during their pertussis illness.
Subjects must have:
Spent > or = 24 consecutive hours in PICU; OR
Spent any time in the PICU and died in the unit
Please review case definitions in the protocol