Impact of Maternal-infant Therapeutics on Safety, Mortality, and Disability
NCT ID: NCT01028183
Last Updated: 2013-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
OBSERVATIONAL
2010-08-31
2013-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of Drug's Risk in Pregnant Women
NCT02818842
Promoting Safe Medication Use in Pregnancy in the Era of Real-World Data - The SafeStart Study
NCT04182750
A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
NCT03842189
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Antenatal Thyrotropin-Releasing Hormone in Pregnant Women With Threatened Premature Delivery
NCT00004778
Pregnancy Surveillance Program of Patients Exposed to Epidiolex/Epidyolex During Pregnancy
NCT06113237
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Extremely Premature Infants
\< 30 weeks gestation (N=5000)
No interventions assigned to this group
Premature Infants
30-36 weeks gestation (N=2000)
No interventions assigned to this group
Hospitalized Term Infants
\>=37 weeks gestation (N=2000)
No interventions assigned to this group
Healthy Term Infants
\>=37 weeks gestation (N=1000)
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* \<=5 days of life
* likely to follow-up at 18 months adjusted age
Exclusion Criteria
5 Days
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Duke University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Duke Clinical Research Institute
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Daniel K Benjamin, MD PhD MPH
Role: PRINCIPAL_INVESTIGATOR
Duke Clinical Research Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Duke Clinical Research Institute
Durham, North Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB pending
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.