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NCT04985227 · ClinicalTrials.gov registry record · NA
Impact of Home Weight Tele-monitoring on the Number of Office Visits in the First Six Weeks of Life in Infants.
A NA study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT04985227 is a NA study that has completed, run by The Cleveland Clinic. The registered enrollment target is 40 participants.
The verdict
NCT04985227, a NA study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study Summary
Currently American Academy of Pediatrics (AAP) Bright Futures Guideline recommends 2 visits for all healthy term newborn infants in the first 6 weeks of life, first at 3-5 days of life and the second at around a month. However, compliant parents of infants are known to get at least 1-2 extra visits due to primary care provider's concern about appropriate weight gain. These weight check visits as they take up extra time, car gas, parking charges, loss of work time and paying for childcare during the visits. Clinic resources are also unnecessarily utilized. Remote home monitoring of infant weights with the use of technology could reduce the need for office visits and improve efficiency on the provider side, enhance parental satisfaction and decrease transmission of viruses in the winter season. The main objective is to monitor the daily weight of term infants born at 37 completed weeks of greater, discharged from the newborn nursery, remotely through the electronic medical record by the primary care provider and to reduce any extra visit in the first six weeks of life. Using block randomization, the infants will be assigned to either group A, where no home telemonitoring of weight will take place or group B, where the parent will be provided with a weighing scale. The parent will enter the weight into the MyChart application on the smartphone or on the computer which will be tracked by the pediatrician. The pediatrician will take the decision whether to bring the infant in for a weight check visit based on the weight information. If the weight gain is satisfactory, the pediatrician will see the patient at around 1 month of age per recommendation and the parents will stop the weight checks at that time. The sample size required was 16 on each arm (total 32) which has been increased to 20 each arm to account for technical problems and/or loss to follow up.
Interventions
- OTHER Home weight monitoring
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2021-08-09 |
| Est. Completion | 2023-02-24 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04985227
The ClinicalTrials.gov registry entry for NCT04985227 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Home weight monitoring is the first listed.
NCT04985227 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04985227 about?
NCT04985227 is a clinical study titled "Impact of Home Weight Tele-monitoring on the Number of Office Visits in the First Six Weeks of Life in Infants.". Currently American Academy of Pediatrics (AAP) Bright Futures Guideline recommends 2 visits for all healthy term newborn infants in the first 6 weeks of life, first at 3-5 days of life and the second at around a month. However, compliant parents of infants are known to get at least 1-2 extra visits ...
What is the current status of trial NCT04985227?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2021-08-09. Estimated completion is 2023-02-24.
What interventions are being tested in trial NCT04985227?
The interventions under investigation include: Home weight monitoring (OTHER).
Who is sponsoring clinical trial NCT04985227?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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