Pilot: Feasibility of Intermittent Enteral Feeding in Ventilated MICU

Status Completed

Clinical Trial Summary

Specific Aims: Aim 1: Evaluate the feasibility of intermittent feeding in intensive care unit patients who are mechanically ventilated. Aim 2: Evaluate the safety and patient tolerance of intermittent feeding in intensive care unit patients who are mechanically ventilated. Aim 3: Determine efficacy of intermittent feeding in provision of required nutrition in mechanically ventilated intensive care unit patients. Aim 4: Determine association of intermittent enteral feeding with glycemic control in mechanically ventilated intensive care unit patients.

Clinical Trial Description

With the advent of the feeding pump, default enteral nutrition schedules in many medical intensive care units has shifted from intermittent or bolus feeding to continuous feeds. Clinical studies suggest that each of these strategies of providing nutrition is safe for patients with no significant difference in glycemic control or adverse effects. There is also data to suggest that approximating a more physiologic nutrition schedule with periods of feeding and periods of fasting may optimize gastrointestinal and metabolic hormonal feedback loops thereby effecting outcomes such as gastrointestinal motility, protein synthesis, and glycemic control, among others. Circadian rhythm research supports a temporally restricted period of feeding as well. Furthermore, periods of scheduled fasting will allow for provision of care that is incompatible with enteral feeds, without interrupting administration of nutrition (for example, procedures or testing, incompatible medications, etc). Aims 1 and 2 will clarify whether an intermittent enteral nutrition schedule is acceptable to ICU staff and patients. Aims 3 and 4 will test whether this enteral feeding schedule is effective in providing patients with required nutrition and acceptable glycemic control. This pilot will set the stage for a randomized controlled trial further investigating superiority of intermittent feeding as compared with the current standard of continuous feeding. ;

Study Design

Related Conditions & MeSH terms

Nutrition

Clinical Trial Details

NCT number	NCT04164108
Study type	Interventional
Source	Yale University
Contact
Status	Completed
Phase	N/A
Start date	November 18, 2019
Completion date	March 18, 2020

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Pilot: Feasibility of Intermittent Enteral Feeding in Ventilated MICU Patients

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms