RecruitingNot Applicable

Supporting Safe Use of Medications by Parents After Infant Discharge From the Neonatal Intensive Care Unit

United States425 participantsStarted 2021-03-10

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. English or Spanish-speaking
. 18 years of age and older
. Child discharged home with a Rx for \>1 daily liquid medication (other than multivitamin)
. Primary person who will administers child's medications.
. Willingness and ability to participate

Exclusion criteria

. Does not have a working phone number
. Does not have access to internet (via computer/smartphone)
. Does not have a mobile phone that receives texts.
. Not able to return to the hospital for their child's follow-up visit
. Visual acuity worse than 20/50 according to the Rosenbaum Pocket Screener
. Uncorrectable hearing impairment

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Improvement in Dosing with HELPix+TECH and HELPix in comparison to usual care.

Timeframe: Visit 3 (Day 30)

Improvement in medication adherence with HELPix+TECH and HELPix in comparison to usual care

Timeframe: Visit 3 (Day 30)

Trial details

NCT IDNCT04278690

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Hsiang Shonna Yin

646-501-4284 hsiang.yin@nyulangone.org

View on ClinicalTrials.gov More Medication Administered in Error trials