Ureaplasma Species and Hyperammonemia in Neonates
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-008104
Sponsor Protocol Number: 16-008104
About this study
This study will compare plasma ammonia levels among neonates with and without Ureaplasma colonization of their respiratory tract. It will compare neonates with and without Ureaplasma colonization to identify differences in clinical characteristics, including gestational age, mode of delivery, comorbidities, and clinical status. It will also compare neonates with and without hyperammonemia to identify differences in clinical characteristics, including gestational age, mode of delivery, comorbidities, and clinical status.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Neonates within the first 72 hours of life admitted to the NICU or ISCN.
Exclusion Criteria:
- Neonates older than 72 hours.
- Neonates admitted to the Newborn Nursery (Level I nursery) at Rochester Methodist Hospital.
- Neonates with a metabolic disorder known to cause hyperammonemia.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Robin Patel, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available