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

Gastroesophageal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01028183
• Other study ID #: IRB pending
• Status: Withdrawn
• Phase: N/A
• First received: December 5, 2009
• Last updated: January 15, 2013
• Start date: August 2010
• Est. completion date: July 2013

Study information

• Verified date: January 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2013
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Days

Eligibility

Inclusion Criteria:

• Admitted to the a Pediatrix Medical Group NICU

• <=5 days of life

• likely to follow-up at 18 months adjusted age

Exclusion Criteria:

• failure to consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Lung Disease
• Ductus Arteriosus, Patent
• Gastroesophageal Reflux
• Lung Diseases
• Neurodevelopmental Impairment
• Patent Ductus Arteriosus
• Presumed Sepsis

Locations

Country	Name	City	State
United States	Duke Clinical Research Institute	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States,