Gastroesophageal RefluxNCT01028183
Impact of Maternal-infant Therapeutics on Safety, Mortality, and Disability
An observational study of Gastroesophageal Reflux and Presumed Sepsis, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 5 days
- Conditions the study is for
- Gastroesophageal Reflux, Presumed Sepsis, Patent Ductus Arteriosus
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 days
- All sexes
- No healthy volunteers
- Child
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).
Who may be able to join
- Admitted to the a Pediatrix Medical Group NICU
- <=5 days of life
- likely to follow-up at 18 months adjusted age
Who cannot join
- failure to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Clinical Research Institute
Durham, North Carolina, 27715
About this study
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.
Read more
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
- Medical subject headings
- Gastroesophageal Reflux, Ductus Arteriosus, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startAug 2010
- Primary completionJul 2011 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Investigators
- Daniel K Benjamin, MD PhD MPH, Principal investigator, Duke Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01028183
- Sponsor's protocol ID
- IRB pending
- Status last verified
- Jan 2013
- First submitted
- 5 Dec 2009
- Last updated
- 16 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Maternal-infant Therapeutics on Safety, Mortality, and Disability
- ClinicalTrials.gov ID
- NCT01028183
- Acronym / sponsor ID
- IRB pending
- Conditions
- Gastroesophageal Reflux, Presumed Sepsis, Patent Ductus Arteriosus, Chronic Lung Disease, Neurodevelopmental Impairment
- Keywords
- therapeutics, safety, maternal, neonatal
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 9 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- Up to 5 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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).
Key inclusion criteria (3 listed)
- Admitted to the a Pediatrix Medical Group NICU
- <=5 days of life
- likely to follow-up at 18 months adjusted age
Key exclusion criteria (1 listed)
- failure to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel K Benjamin, MD PhD MPH principal investigator
Duke Clinical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux and Presumed Sepsis, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2013.