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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT01028183
First received: December 5, 2009
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Maternal-infant Therapeutics on Safety, Mortality, and Disability

Resource links provided by NLM:


Further study details as provided by Duke University:

Enrollment: 0
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)
Groups/Cohorts
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

Ages Eligible for Study:   up to 5 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01028183

Locations
United States, North Carolina
Duke Clinical Research Institute
Durham, North Carolina, United States, 27715
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Daniel K Benjamin, MD PhD MPH Duke Clinical Research Institute
  More Information

No publications provided

Responsible Party: Daniel K Benjamin Jr MD PhD MPH, Associate Professor of Pediatrics, Duke Clinical Research Institute
ClinicalTrials.gov Identifier: NCT01028183     History of Changes
Other Study ID Numbers: IRB pending
Study First Received: December 5, 2009
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
therapeutics
safety
maternal
neonatal

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Gastroesophageal Reflux
Lung Diseases
Sepsis
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Respiratory Tract Diseases
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on April 15, 2014