Respiratory Distress Syndrome, AdultPhase 3EDENNCT00883948
Early Versus Delayed Enteral Feeding to Treat People With Acute Lung Injury or Acute Respiratory Distress Syndrome (The EDEN Study)
A Phase 3 study testing Minimal (Trophic) Feeding and Full Feeding in people with Respiratory Distress Syndrome, Adult, run by National Heart, Lung, and Blood Institute (NHLBI) at 39 sites in United States.
Trial summary
Acute respiratory distress syndrome (ARDS) and acute lung injury (ALI) are medical conditions that occur when there is severe inflammation and increased fluids in both lungs, making it difficult for the lungs to function properly. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Respiratory Distress Syndrome, Adult
- What is being tested?
- Minimal (Trophic) Feeding and Full Feeding
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 39 sitesUnited States
- Study dates
- Dec 2007to May 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Must meet the following three criteria within a 24-hour period of study entry: 1) PaO2/FiO2 less than or equal to 300 (if altitude is more than 1000 meters, then PaO2/FiO2 less than or equal to 300 x [barometric pressure/760]), 2) bilateral infiltrates (patchy, diffuse, homogeneous, or asymmetric) consistent with pulmonary edema on frontal chest radiograph, and 3) requirement for positive pressure ventilation via endotracheal tube
- No clinical evidence of left-sided cardiac failure to account for bilateral pulmonary infiltrates
- Intention of primary medical team to enterally feed the patient
- Undergoes enteral feeding within 48 hours of meeting other inclusion criteria
Who cannot join
- Neuromuscular disease that impairs ability to breathe without assistance, such as cervical spinal cord injury at level C5 or higher, amyotrophic lateral sclerosis, Guillain-Barré syndrome, or myasthenia gravis
- Pregnant or breastfeeding
- Severe chronic respiratory disease (more information about this criterion can be found in the protocol)
- Burns on greater than 40% total body surface area
- Cancer or other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50% (more information about this criterion can be found in the protocol)
- Allogeneic bone marrow transplant in the 5 years before study entry
Show all 28Show fewer
- Patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)
- Severe long-term liver disease (Child-Pugh score of 11 to 15)
- Diffuse alveolar hemorrhage from vasculitis
- Morbid obesity, defined as 1 kg/cm body weight
- Unwilling or unable to use the ARDS network 6 mL/kg PBW ventilation protocol
- Moribund patient not expected to survive 24 hours after study entry
- No intent to obtain central venous access for monitoring intravascular pressures
- More than 72 hours since mechanical ventilation initiated
- Refractory shock (more information about this criterion can be found in the protocol)
- Unable to obtain enteral access
- Presence of partial or complete mechanical bowel obstruction
- Presence of ischemia or infarction
- Current total parenteral nutrition (TPN) use or intent to use TPN within 7 days of study entry
- Severe malnutrition with body mass index less than 18.5 or loss of more than 30% total body weight in the 6 months before study entry
- Laparotomy expected within 7 days of study entry
- Unable to raise head of bed 30 to 45 degrees
- Short-bowel syndrome or absence of gastrointestinal tract
- Presence of high-output (greater than 500 cc/day) enterocutaneous fistula
- International normalized ratio greater than 5.0, platelet count less than 30,000/mm3, or history of bleeding disorder
- Intracranial hemorrhage in the 1 month before study entry
- Allergy to enteral formula
- Requirement for, or physician insistence on, enteral formula supplemented with omega-3 fatty acids (e.g., Oxepa®, Impact®) or treatment with omega-3 fatty acid, gamma-linolenic acid (GLA), or antioxidant supplementation
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
Johns Hopkins Bayview Medical Center
Baltimore, Maryland
Johns Hopkins Hospital
Baltimore, Maryland
Union Memorial Hospital
Baltimore, Maryland
University of Maryland Shock Trauma Center
Baltimore, Maryland
Baton Rouge General Hospital-Blue Bonnet
Baton Rouge, Louisiana
Baton Rouge General Hospital-Midcity
Baton Rouge, Louisiana
Earl K. Long Medical Center
Baton Rouge, Louisiana
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana
University of Virginia Medical Center
Charlottesville, Virginia
Cleveland Clinic Foundation
Cleveland, Ohio
MetroHealth Medical Center
Cleveland, Ohio
University Hospitals of Cleveland
Cleveland, Ohio
Centura St. Anthony Central Hospital
Denver, Colorado
Denver Health Medical Center
Denver, Colorado
Rose Medical Center
Denver, Colorado
University of Colorado Health Sciences Center
Denver, Colorado
Duke University Medical Center
Durham, North Carolina
Durham Regional Medical Center
Durham, North Carolina
University of San Francisco-Fresno Medical Center
Fresno, California
Moses Cone Health System
Greensboro, North Carolina
Wesley Long Community Hospital
Greensboro, North Carolina
Baylor College of Medicine
Houston, Texas
Intermountain Medical Center
Murray, Utah
Vanderbilt University Medical Center
Nashville, Tennessee
Medical Center of Louisiana
New Orleans, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana
Tulane University Health Sciences Center
New Orleans, Louisiana
McKay-Dee Hospital
Ogden, Utah
Utah Valley Regional Medical Center
Provo, Utah
Rochester Methodist Hospital
Rochester, Minnesota
St. Mary's Hospital, Mayo Clinic
Rochester, Minnesota
University of California, Davis Medical Center
Sacramento, California
LDS Hospital
Salt Lake City, Utah
University of California, San Francisco (UCSF)-Moffitt Hospital
San Francisco, California
Harborview Medical Center
Seattle, Washington
University of Washington
Seattle, Washington
Baystate Medical Center
Springfield, Massachusetts
Washington Hospital Center
Washington D.C., District of Columbia
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina
About this study
Official title: Prospective, Randomized, Multi-Center Trial of Initial Trophic Enteral Feeding Followed by Advancement to Full-Calorie Enteral Feeding vs. Early Advancement to Full-Calorie Enteral Feeding in Patients With Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS)
Acute respiratory distress syndrome (ARDS) and acute lung injury (ALI) are medical conditions that occur when there is severe inflammation and increased fluids in both lungs, making it difficult for the lungs to function properly. Hospital treatment for a person with ALI/ARDS often includes the use of a breathing machine, or ventilator, until the person is able to breathe without assistance. Initiating proper nutrition through a feeding tube early in a person's hospital stay may help to improve recovery, but the optimal timing, composition, and amount of feeding treatments remain unknown. This study will evaluate whether early or delayed full-calorie feeding through a feeding tube is more effective in reducing recovery time and increasing survival rates in people with ALI/ARDS.
Read the detailed description
ALI/ARDS involves extensive inflammation in the lungs that can lead to rapid respiratory failure. These conditions are most commonly caused by pneumonia, generalized infection, or severe trauma to the lungs, but can also be less commonly caused by smoke or salt water inhalation, drug overdose, or shock.
For some people, ALI/ARDS resolves without treatment, but many severe cases result in hospitalization in the intensive care unit (ICU), where 30% to 40% of cases end in mortality. Current treatments for ALI/ARDS include assisted breathing with a ventilator, supportive care, and management of the underlying causes. Enteral feeding, in which patients receive nutrition through a feeding tube, plays an important role in treatment, too. Some recent studies have shown that enteral feeding initiated soon after a patient begins assisted breathing is associated with a shorter hospital stay and a better chance of survival than delayed enteral feeding. However, other studies have shown the opposite, and studies on optimal feeding volume and composition have shown conflicting results. This study will evaluate the effects of early versus delayed full-calorie enteral feeding on mortality, ventilator-free days, ICU-free days, and organ failure in people with ALI/ARDS.
Upon admission to the ICU, a dietary evaluation will be done on each participant to determine goal, or full-calorie, feeding rates, which will be based on body weight and daily energy consumption. Participants will also undergo baseline assessments and procedures, which will include vital sign measurements, blood draws, a frontal chest radiograph, ventilator settings, and placement of a feeding tube. Participants will be randomly assigned to receive initial enteral feedings that are either minimal (trophic) or full-calorie. All participants will begin enteral feeding within 6 hours of treatment assignment.
Participants assigned to initial minimal enteral feedings will receive feedings at 10 cubic centimeters (cc) per hour, to be continued at this rate for 144 hours, provided that the participant remains on the ventilator. After the 144 hours, the feeding rate will be advanced to full-calorie rates.
Participants assigned to initial full-calorie enteral feedings will receive feedings at 25 cc per hour, and the feeding rate will be increased by 25 cc per hour every 6 hours until the goal rate is reached. During enteral feedings, gastric residual volumes (GRVs) will be checked every 6 to 12 hours to assure acceptable levels. Participants will complete enteral feedings upon hospital discharge, Day 28 of treatment, death, or ability to achieve 48 hours of unassisted breathing.
Blood pressure, heart rate, ventilation settings, and various blood factors will be measured during treatment. Phone-based follow-up assessments will occur at Months 6 and 12 after ICU discharge and will include measurements of health-related quality of life; psychological, neurocognitive, and physical activity outcomes; healthcare utilization; and mortality.
- Conditions
- Respiratory Distress Syndrome, Adult
- Being tested
- Minimal (Trophic) Feeding, Full Feeding
- Keywords
- Acute Lung Injury, Acute Respiratory Distress Syndrome, Feeding, Critical Care, Ventilator
- Medical subject headings
- Respiratory Distress Syndrome, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal (Trophic) FeedingBehavioural
Upon admission to the ICU, enteral feeds will be started at 10 cc per hour and continued at this rate for 144 hours. After 144 hours of trophic enteral feeds, the feeding rate will be advanced to full-calorie rates, which will continue for the duration of mechanical ventilation up to Day 28.
Full FeedingBehavioural
Upon admission to the ICU, a full-calorie feeding rate will be determined, which will be calculated to deliver 25 to 35 kcal/kg predicted body weight (PBW) each day. Enteral feeds will be initiated at 25 cc per hour. The feeding rate will be increased by 25 cc per hour every 6 hours until goal rate is achieved, which will be administered for the duration of mechanical ventilation up to Day 28.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive initial minimal (trophic) enteral feeding. Receives: Behavioral: Minimal (Trophic) Feeding |
| 2 | Experimental | Participants will receive initial full-calorie enteral feeding. Receives: Behavioral: Full Feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ventilator-free days (VFD)
Measured: Measured at Day 28
Mortality before hospital discharge, with unassisted breathing
Measured: Measured at Days 60 and 90
Secondary outcomes (8)
Number of intensive care unit-free days
Measured: Measured at Day 28
Number of organ failure-free days (liver, kidney, heart, central nervous system, and hematologic)
Measured: Measured at Day 28
Incidence of ventilator-associated pneumonia
Measured: Measured at Day 28
Number of days from first meeting criteria for weaning readiness to Day 28
Measured: Measured at Day 28
VFDs and mortality in participants with a partial pressure of oxygen in arterial blood (PaO2)/fraction of inspired oxygen (FIO2) less than or equal to 200 or with shock at the time of study entry
Measured: Measured at Days 28 and 60, respectively
Change in plasma and mini-bronchoalveolar lavage (BAL) levels of interleukin (IL)-6, IL-8, von Willebrand factor (VWF), surfactant protein D (SPD), and total protein concentrations
Measured: Measured at Day 3
Health-related quality of life; healthcare utilization; and psychological, neurocognitive, and physical activity outcomes
Measured: Measured at Months 6 and 12
Duration of survival after hospital discharge using the National Death Index
Measured: Measured at Months 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2009 (estimated)
- Study startDec 2007
- Primary completionMar 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome, AdultStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Arthur P. Wheeler, MD, Study chair, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00883948
- Sponsor's protocol ID
- 651
- Other IDs
- N01-HR056179, HSN268200536179C, N01HR056179
- Acronym
- EDEN
- Status last verified
- Feb 2012
- First submitted
- 17 Apr 2009
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brown SM, Wilson E, Presson AP, Zhang C, Dinglas VD, Greene T, Hopkins RO, Needham DM; with the National Institutes of Health NHLBI ARDS Network. Predictors of 6-month health utility outcomes in survivors of acute respiratory distress syndrome. Thorax. 2017 Apr;72(4):311-317. doi: 10.1136/thoraxjnl-2016-208560. Epub 2016 Jul 20.
PubMed 27440140National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Rice TW, Wheeler AP, Thompson BT, Steingrub J, Hite RD, Moss M, Morris A, Dong N, Rock P. Initial trophic vs full enteral feeding in patients with acute lung injury: the EDEN randomized trial. JAMA. 2012 Feb 22;307(8):795-803. doi: 10.1001/jama.2012.137. Epub 2012 Feb 5.
PubMed 22307571
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Multi-Center Trial of Initial Trophic Enteral Feeding Followed by Advancement to Full-Calorie Enteral Feeding vs. Early Advancement to Full-Calorie Enteral Feeding in Patients With Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS)
- ClinicalTrials.gov ID
- NCT00883948
- Acronym / sponsor ID
- EDEN / 651
- Conditions
- Respiratory Distress Syndrome, Adult
- Keywords
- Acute Lung Injury, Acute Respiratory Distress Syndrome, Feeding, Critical Care, Ventilator
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Dec 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 20 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute respiratory distress syndrome (ARDS) and acute lung injury (ALI) are medical conditions that occur when there is severe inflammation and increased fluids in both lungs, making it difficult for the lungs to function properly. Hospital treatment for a person with ALI/ARDS often includes the use of a breathing machine, or ventilator, until the person is able to breathe without assistance. Initiating proper nutrition through a feeding tube early in a person's hospital stay may help to improve recovery, but the optimal timing, composition, and amount of feeding treatments remain unknown. This study will evaluate whether early or delayed full-calorie feeding through a feeding tube is more effective in reducing recovery time and increasing survival rates in people with ALI/ARDS.
Detailed description
ALI/ARDS involves extensive inflammation in the lungs that can lead to rapid respiratory failure. These conditions are most commonly caused by pneumonia, generalized infection, or severe trauma to the lungs, but can also be less commonly caused by smoke or salt water inhalation, drug overdose, or shock.
For some people, ALI/ARDS resolves without treatment, but many severe cases result in hospitalization in the intensive care unit (ICU), where 30% to 40% of cases end in mortality. Current treatments for ALI/ARDS include assisted breathing with a ventilator, supportive care, and management of the underlying causes. Enteral feeding, in which patients receive nutrition through a feeding tube, plays an important role in treatment, too. Some recent studies have shown that enteral feeding initiated soon after a patient begins assisted breathing is associated with a shorter hospital stay and a better chance of survival than delayed enteral feeding. However, other studies have shown the opposite, and studies on optimal feeding volume and composition have shown conflicting results. This study will evaluate the effects of early versus delayed full-calorie enteral feeding on mortality, ventilator-free days, ICU-free days, and organ failure in people with ALI/ARDS.
Upon admission to the ICU, a dietary evaluation will be done on each participant to determine goal, or full-calorie, feeding rates, which will be based on body weight and daily energy consumption. Participants will also undergo baseline assessments and procedures, which will include vital sign measurements, blood draws, a frontal chest radiograph, ventilator settings, and placement of a feeding tube. Participants will be randomly assigned to receive initial enteral feedings that are either minimal (trophic) or full-calorie. All participants will begin enteral feeding within 6 hours of treatment assignment.
Participants assigned to initial minimal enteral feedings will receive feedings at 10 cubic centimeters (cc) per hour, to be continued at this rate for 144 hours, provided that the participant remains on the ventilator. After the 144 hours, the feeding rate will be advanced to full-calorie rates.
Participants assigned to initial full-calorie enteral feedings will receive feedings at 25 cc per hour, and the feeding rate will be increased by 25 cc per hour every 6 hours until the goal rate is reached. During enteral feedings, gastric residual volumes (GRVs) will be checked every 6 to 12 hours to assure acceptable levels. Participants will complete enteral feedings upon hospital discharge, Day 28 of treatment, death, or ability to achieve 48 hours of unassisted breathing.
Blood pressure, heart rate, ventilation settings, and various blood factors will be measured during treatment. Phone-based follow-up assessments will occur at Months 6 and 12 after ICU discharge and will include measurements of health-related quality of life; psychological, neurocognitive, and physical activity outcomes; healthcare utilization; and mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Minimal (Trophic) FeedingParticipants will receive initial minimal (trophic) enteral feeding. |
| 2 | Experimental | Behavioral: Full FeedingParticipants will receive initial full-calorie enteral feeding. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Must meet the following three criteria within a 24-hour period of study entry: 1) PaO2/FiO2 less than or equal to 300 (if altitude is more than 1000 meters, then PaO2/FiO2 less than or equal to 300 x [barometric pressure/760]), 2) bilateral infiltrates (patchy, diffuse, homogeneous, or asymmetric) consistent with pulmonary edema on frontal chest radiograph, and 3) requirement for positive pressure ventilation via endotracheal tube
- No clinical evidence of left-sided cardiac failure to account for bilateral pulmonary infiltrates
- Intention of primary medical team to enterally feed the patient
- Undergoes enteral feeding within 48 hours of meeting other inclusion criteria
Key exclusion criteria (28 listed)
- Neuromuscular disease that impairs ability to breathe without assistance, such as cervical spinal cord injury at level C5 or higher, amyotrophic lateral sclerosis, Guillain-Barré syndrome, or myasthenia gravis
- Pregnant or breastfeeding
- Severe chronic respiratory disease (more information about this criterion can be found in the protocol)
- Burns on greater than 40% total body surface area
- Cancer or other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50% (more information about this criterion can be found in the protocol)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimal (Trophic) FeedingUpon admission to the ICU, enteral feeds will be started at 10 cc per hour and continued at this rate for 144 hours. After 144 hours of trophic enteral feeds, the feeding rate will be advanced to full-calorie rates, which will continue for the duration of mechanical ventilation up to Day 28. | Behavioural | 1 |
| Full FeedingUpon admission to the ICU, a full-calorie feeding rate will be determined, which will be calculated to deliver 25 to 35 kcal/kg predicted body weight (PBW) each day. Enteral feeds will be initiated at 25 cc per hour. The feeding rate will be increased by 25 cc per hour every 6 hours until goal rate is achieved, which will be administered for the duration of mechanical ventilation up to Day 28. | Behavioural | 2 |
Primary outcome
Number of ventilator-free days (VFD)
Time frame: Measured at Day 28
Mortality before hospital discharge, with unassisted breathing
Time frame: Measured at Days 60 and 90
8 secondary outcomes
Number of intensive care unit-free days
Time frame: Measured at Day 28
Number of organ failure-free days (liver, kidney, heart, central nervous system, and hematologic)
Time frame: Measured at Day 28
Incidence of ventilator-associated pneumonia
Time frame: Measured at Day 28
Number of days from first meeting criteria for weaning readiness to Day 28
Time frame: Measured at Day 28
VFDs and mortality in participants with a partial pressure of oxygen in arterial blood (PaO2)/fraction of inspired oxygen (FIO2) less than or equal to 200 or with shock at the time of study entry
Time frame: Measured at Days 28 and 60, respectively
Change in plasma and mini-bronchoalveolar lavage (BAL) levels of interleukin (IL)-6, IL-8, von Willebrand factor (VWF), surfactant protein D (SPD), and total protein concentrations
Time frame: Measured at Day 3
Health-related quality of life; healthcare utilization; and psychological, neurocognitive, and physical activity outcomes
Time frame: Measured at Months 6 and 12
Duration of survival after hospital discharge using the National Death Index
Time frame: Measured at Months 6 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
- Derived from this study: PubMed 27440140Brown SM, Wilson E, Presson AP, Zhang C, Dinglas VD, Greene T, Hopkins RO, Needham DM; with the National Institutes of Health NHLBI ARDS Network. Predictors of 6-month health utility outcomes in survivors of acute respiratory distress syndrome. Thorax. 2017 Apr;72(4):311-317. doi: 10.1136/thoraxjnl-2016-208560. Epub 2016 Jul 20.
- Derived from this study: PubMed 22307571National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Rice TW, Wheeler AP, Thompson BT, Steingrub J, Hite RD, Moss M, Morris A, Dong N, Rock P. Initial trophic vs full enteral feeding in patients with acute lung injury: the EDEN randomized trial. JAMA. 2012 Feb 22;307(8):795-803. doi: 10.1001/jama.2012.137. Epub 2012 Feb 5.
- Click here for the NHLBI Acute Respiratory Distress Syndrome Network Web siteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arthur P. Wheeler, MD study chair
Vanderbilt University Medical Center
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Minimal (Trophic) Feeding and Full Feeding in people with Respiratory Distress Syndrome, Adult, run by National Heart, Lung, and Blood Institute (NHLBI) at 39 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of ventilator-free days (VFD) (time frame: Measured at Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00883948, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2016.