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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01028183
Recruitment Status : Withdrawn
First Posted : December 9, 2009
Last Update Posted : January 16, 2013
Information provided by:
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.

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

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Maternal-infant Therapeutics on Safety, Mortality, and Disability
Study Start Date : August 2010
Estimated Primary Completion Date : July 2011
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Coal Tar
U.S. FDA Resources

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)

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Days   (Child)
Sexes Eligible for Study:   All
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).

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01028183

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

Responsible Party: Daniel K Benjamin Jr MD PhD MPH, Associate Professor of Pediatrics, Duke Clinical Research Institute Identifier: NCT01028183     History of Changes
Other Study ID Numbers: IRB pending
First Posted: December 9, 2009    Key Record Dates
Last Update Posted: January 16, 2013
Last Verified: January 2013

Keywords provided by Duke University:

Additional relevant MeSH terms:
Lung Diseases
Gastroesophageal Reflux
Ductus Arteriosus, Patent
Respiratory Tract Diseases
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Coal Tar
Keratolytic Agents
Dermatologic Agents