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

NCT01028183 | Withdrawn DMC

• 1 other identifier: IRB pending
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

therapeutics; safety; maternal; neonatal

Study Arms (4)

Extremely Premature Infants

\< 30 weeks gestation (N=5000)

Premature Infants

30-36 weeks gestation (N=2000)

Hospitalized Term Infants

\>=37 weeks gestation (N=2000)

Healthy Term Infants

\>=37 weeks gestation (N=1000)

Eligibility Criteria

• Age: Up to 5 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

We will enroll 10,000 infants at 40 centers. Infants will be enrolled into one of four strata: extremely premature (\<30 weeks, n=5,000), premature (30-36 weeks inclusive n=2,000), hospitalized term (≥37 weeks gestation, n=2,000), and healthy term (≥37 weeks gestation, n=1,000).

You may qualify if:

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

You may not qualify if:

• failure to consent

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Clinical Research Institute

Durham, North Carolina, 27715, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Ductus Arteriosus, Patent

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Daniel K Benjamin, MD PhD MPH

  Duke Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 5, 2009
• First Posted: December 9, 2009
• Study Start: August 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2013
• Last Updated: January 16, 2013

Record last verified: 2013-01

Locations

US (1)