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

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ClinicalTrials.gov Identifier: NCT01028183
Recruitment Status : Withdrawn
First Posted : December 9, 2009
Last Update Posted : January 16, 2013
Information provided by:
Duke University

December 5, 2009
December 9, 2009
January 16, 2013
August 2010
July 2011   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01028183 on ClinicalTrials.gov Archive Site
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Impact of Maternal-infant Therapeutics on Safety, Mortality, and Disability
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.

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Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
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).
  • Gastroesophageal Reflux
  • Presumed Sepsis
  • Patent Ductus Arteriosus
  • Chronic Lung Disease
  • Neurodevelopmental Impairment
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  • 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)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
July 2013
July 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 5 Days   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
IRB pending
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Daniel K Benjamin Jr MD PhD MPH, Associate Professor of Pediatrics, Duke Clinical Research Institute
Duke University
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Principal Investigator: Daniel K Benjamin, MD PhD MPH Duke Clinical Research Institute
Duke University
January 2013