Gastroesophageal Reflux Clinical Trial
Official title:
Impact of Maternal-infant Therapeutics on Safety, Mortality, and Disability
The purpose of this research is to address the comparative effectiveness and harm of the
therapeutics frequently given to pregnant women and their young infants including
antibiotics, tocolytic agents, non-steroidal anti-inflammatory drugs, H2 blockers, and
steroids.
Our overall hypothesis is that the use of an existing electronic medical record with
additional resources for precise data collection and 18 month follow up will successfully
address current knowledge gaps in therapeutic effectiveness and relative therapeutic harm.
We will use an existing electronic medical record into which detailed healthcare information
is entered for over 100,000 newborns each year. These infants will comprise the "Source
Cohort". Nested within that database, we will prospectively enroll 10% of the population
(10,000 newborns) as the Follow-Up Cohort.
The current electronic medical record for the Source Cohort does not capture therapeutic
dosing with sufficient precision to conduct comparative effectiveness research sufficient to
change medical practice. The proposed research will: 1) ensure accurate data collection
through electronic monitoring and real-time quality assurance evaluation in the Source
Cohort; and 2) conduct 18 months post-hospital follow-up for neurologic outcomes and
disability for the Follow-Up Cohort. We will complete assessments of neurologic outcomes and
disability using an interactive web-based system, mail, telephone follow up, and in-person
examination.
n/a
Observational Model: Cohort, Time Perspective: Prospective
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