Impact of Maternal-infant Therapeutics on Safety, Mortality, and Disability

Withdrawn

• Conditions: Gastroesophageal Reflux; Presumed Sepsis; Patent Ductus Arteriosus; Chronic Lung Disease; Neurodevelopmental Impairment

• Registration Number: NCT01028183
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-12-05
• Study First Submitted QC: 2009-12-08
• Study First Posted: 2009-12-09
• Study Start: 2010-08
• Primary Completion: 2011-07
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-15
• Last Update Posted: 2013-01-16
• Study Completion: 2013-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Admitted to the a Pediatrix Medical Group NICU
• <=5 days of life
• likely to follow-up at 18 months adjusted age

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Exclusion Criteria

• failure to consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Duke Clinical Research Institute; 🇺🇸 Durham, North Carolina, United States