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Enteric feeding for Intensive Care Unit Delirium

Led By Deepali Dixit, PharmD
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Screening 3 weeks
Treatment Varies
Follow Up 48 hours after admission to the icu.
Awards & highlights

Study Summary

This trial will investigate whether feeding schedules influence the development of delirium in ICU patients on mechanical ventilation. Patients will be randomized to receive either continuous or scheduled feedings, and assessed for delirium, sleep quality, and biomarkers of circadian rhythm.

Who is the study for?
This trial is for ICU patients on mechanical ventilation who are receiving tube feedings and have been in the ICU for at least 48 hours. It's not open to pregnant individuals, those with past neurocognitive disorders, or a history of alcohol dependence.Check my eligibility
What is being tested?
The study is looking into whether changing feeding times can affect delirium development in ventilated ICU patients. Participants will be split randomly into two groups: one with continuous feedings and another with scheduled meal-like feedings.See study design
What are the potential side effects?
Since this trial involves standard enteric feeding procedures, side effects may include gastrointestinal discomfort such as bloating or diarrhea, but specific side effects related to the timing of feeds are unknown.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours after admission to the icu.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours after admission to the icu. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Secondary outcome measures
Change in sleep quality assessed using delta power.
Change in sleep quality assessed using theta power.
Change in sleep quality using beta power.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Timed FeedingExperimental Treatment1 Intervention
Enteric feeding will be given four times per day, approximating breakfast, lunch, a snack, and dinner.
Group II: Continuous FeedingActive Control1 Intervention
Enteric feeding will be given continuously.

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Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
429 Previous Clinical Trials
64,192 Total Patients Enrolled
Deepali Dixit, PharmDPrincipal InvestigatorRutgers Ernest Mario School of Pharmacy

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants being recruited for this clinical experiment presently?

"Affirmative, the clinical trial is actively enrolling eligible participants. The listing on clinicaltrials.gov states that it was initially posted in April 2021 and recently updated at the end of June 2022. 40 individuals must be recruited for this study from a single medical clinic."

Answered by AI

Does this investigation include participants aged 40 or older?

"The present clinical trial is aiming to enroll individuals above 21 years old and below the age of 89."

Answered by AI

What is the aggregate enrollment of this research project?

"Affirmative. The clinicaltrials.gov website confirms that this medical study is presently recruiting participants, having been first posted on April 26th 2021 and last updated June 29th 2022. In total, 40 patients need to be enlisted from a single centre for the trial."

Answered by AI

Is this research project open to all eligible participants?

"This trial is seeking 40 individuals aged 21 to 89 that are suffering from delirium. To be considered, patients must have been receiving enteral feedings for a minimum of two days and currently need mechanical ventilation in an ICU setting."

Answered by AI
~0 spots leftby Apr 2024