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.
|Gastroesophageal Reflux Presumed Sepsis Patent Ductus Arteriosus Chronic Lung Disease Neurodevelopmental Impairment|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Impact of Maternal-infant Therapeutics on Safety, Mortality, and Disability|
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Extremely Premature Infants
< 30 weeks gestation (N=5000)
30-36 weeks gestation (N=2000)
Hospitalized Term Infants
>=37 weeks gestation (N=2000)
Healthy Term Infants
>=37 weeks gestation (N=1000)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01028183
|United States, North Carolina|
|Duke Clinical Research Institute|
|Durham, North Carolina, United States, 27715|
|Principal Investigator:||Daniel K Benjamin, MD PhD MPH||Duke Clinical Research Institute|