Gastroesophageal Reflux Clinical Trial
Official title:
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.
n/a
Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05561179 -
Hyaluronic Acid in Patients With Gastroesophageal Reflux Disease
|
N/A | |
| Withdrawn |
NCT02213887 -
Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications
|
Phase 4 | |
| Completed |
NCT01946971 -
Lansoprazole in Preterm Infants With Gastroesophageal Reflux (GER)
|
Phase 1/Phase 2 | |
| Recruiting |
NCT01825473 -
Study of Erythromycin in GER-Associated Apnea of the Newborn
|
N/A | |
| Completed |
NCT00614536 -
Study of Changes in Reflux Symptoms and Reflux Finding Score According to Rabeprazole Treatment Period
|
Phase 4 | |
| Completed |
NCT00365300 -
Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)
|
Phase 3 | |
| Completed |
NCT00373997 -
Esophageal and Laryngeal Tissue Changes in Patients Suspected of Having Laryngopharyngeal Reflux
|
Phase 4 | |
| Completed |
NCT00284908 -
Dose-Effect of S-Tenatoprazole-Na(STU-Na) 30 mg, 60 mg, 90 mg and 120 mg in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT00141960 -
Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease
|
Phase 2/Phase 3 | |
| Completed |
NCT00567021 -
German PMS Trial (AWB) to Evaluate Therapy in Reflux Disease and NSAR-Symptoms
|
N/A | |
| Completed |
NCT00226044 -
Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.
|
Phase 3 | |
| Completed |
NCT01167543 -
Relationship and Pathophysiology of Gastroesophageal Reflux and Dental/Periodontal Disease
|
N/A | |
| Completed |
NCT00291746 -
Validation of RDQ Questionnaire
|
Phase 4 | |
| Completed |
NCT00215787 -
Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease
|
N/A | |
| Completed |
NCT00181805 -
Natural History of Gastroesophageal Reflux (GER) in Children and Adolescents
|
||
| Completed |
NCT01048840 -
Natural History of Gastroesophageal Reflux (GER) in Children < 12 Years of Age
|
||
| Terminated |
NCT01281553 -
A Study of Cisapride in Patients With Symptomatic Gastro-Oesophageal Reflux Disease
|
Phase 4 | |
| Completed |
NCT05486169 -
Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy
|
N/A | |
| Completed |
NCT04034017 -
Gastroesophageal Reflux Disease Among College Students
|
||
| Terminated |
NCT03226054 -
Determining Risk Factors for Successful PPI Weaning
|
N/A |