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NCT04278690 · ClinicalTrials.gov registry record · NA
Supporting Safe Use of Medications by Parents After Infant Discharge From the Neonatal Intensive Care Unit
A NA study of Medication Administered in Error, sponsored by NYU Langone Health.
- Recruiting
- Registry status
- NA
- Development phase
- 425
- Enrollment target
- 1
- Study location
NCT04278690: Recruiting NA study of Medication Administered in Error, sponsored by NYU Langone Health.
NCT04278690 is a NA study of Medication Administered in Error that is actively recruiting participants, run by NYU Langone Health. The registered enrollment target is 425 participants, below the 751-participant average among 3 other Medication Administered in Error trials with a reported enrollment target (43% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04278690, a NA study of Medication Administered in Error, is actively recruiting participants, sponsored by NYU Langone Health.
- RECRUITING
- Registry status
- NA
- Development phase
- 425 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized controlled study of parents of children to be discharged from the neonatal intensive care unit at Bellevue and Elmhurst hospitals. A total of 425 subjects will be recruited across two sites over preparatory phases and two primary study phases.
Primary Outcome
HELPix (health literacy-informed written materials and verbal counseling in addition to usual care) and HELPix+TECH (a health literacy-informed web application in addition to HELPix and usual care) will result in improved dosing compared to usual care alone. This will be assessed by the percentage of observed dosing error (whether clinically meaningful errors of \>20% deviation and/or large error of \>40% deviation).
Conditions Studied
Interventions
- OTHER HELPix
- OTHER HELPix+Tech
Study Locations (1)
New York
- NYU Langone Health - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 425 participants |
| Start Date | 2021-03-10 |
| Est. Completion | 2027-02 |
| Phase | NA |
What NCT04278690 shows while recruiting
NCT04278690 is an interventional study that assigns participants to a tested intervention. The registered 425 participants enrollment target is mid-sized for trials with a published cap, below the 751-participant average among 3 other Medication Administered in Error trials with a reported enrollment target (43% lower).
The record links to 1 condition, with Medication Administered in Error appearing as the primary indexed condition, and to 2 interventions - of which HELPix is the first listed.
NCT04278690 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04278690 about?
NCT04278690 is a clinical study titled "Supporting Safe Use of Medications by Parents After Infant Discharge From the Neonatal Intensive Care Unit". This is a randomized controlled study of parents of children to be discharged from the neonatal intensive care unit at Bellevue and Elmhurst hospitals. A total of 425 subjects will be recruited across two sites over preparatory phases and two primary study phases.
What is the current status of trial NCT04278690?
This trial is currently recruiting. It is a NA study. The enrollment target is 425 participants. The study started on 2021-03-10. Estimated completion is 2027-02.
What conditions does trial NCT04278690 study?
This clinical trial studies the following conditions: Medication Administered in Error.
What interventions are being tested in trial NCT04278690?
The interventions under investigation include: HELPix (OTHER), HELPix+Tech (OTHER).
Who is sponsoring clinical trial NCT04278690?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04278690 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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