A Study to Screen Infant Healthy Growth Assessment and Intervention with Home Visiting
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: 19-003929
Sponsor Protocol Number: 19-003929
About this study
The primary purpose of this study is to develop a screening system for factors that impact growth in infants within the newborn nursery, as well as a feeding assessment survey to be completed at well child visits during the first 12 months of life.
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:
- Infants born at or after 37 weeks gestational age at Methodist hospital in the level 1 nursery, who currently live in Olmsted County, and will receive primary care within Employee Community Health (ECH).
- Infants born to mothers age 18 or older.
- For multi-gestation births, only the first born child is eligible.
- A score of > 3 on the Infant Unhealthy Growth Factor assessment.
- Families who require interpreter services are eligible for the study as OCPHS Family Home Visiting utilizes interpreters and there are interpreters available in the nursery.
Exclusion Criteria:
- Those not meeting the inclusion criteria.
- Families with grandparent(s) as primary caregivers or if infant has been determined in nursery to be going to foster care or CPS.
- Families who have previously qualified for and participated in on-going home visits over a period of months to years or who have recently accepted OCPH home visits to be scheduled in the near future and anticipated to span over months to years.
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 Brian Lynch, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available