Acute Respiratory Failure With HypoxiaPhase 2SuPPeRNCT01937884

Supplemental Parenteral Nutrition in Pediatric Respiratory Failure

A Phase 2 study testing Parenteral Nutrition in people with Acute Respiratory Failure With Hypoxia and Malnutrition, run by University of Arizona at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 1 month to 16 years
Conditions the study is for: Acute Respiratory Failure With Hypoxia, Malnutrition
What is being tested?: Parenteral Nutrition
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: Aug 2013to Aug 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 1 month to 16 years
All sexes
No healthy volunteers
Child

Who may be able to join

Admitted to study hospital pediatric intensive care unit (PICU),
One month to 16 years of age,
Exhibits Acute Hypoxemic Respiratory Failure as defined as: PaO2/FiO2 ≤ 300 or SpO2/FiO2 ≤ 260, No evidence of cardiac dysfunction, Mechanically ventilated,
Require artificial nutrition,
Anticipate placement of central venous line within 24 hours of admission

Who cannot join

Premature infants and neonates < 37 weeks corrected gestational age,
Transfer patient on an established enteral or parenteral nutritional regimen,
Known allergy to lactulose or mannitol,
Pregnant,
Admit BMI >30,
Thoracic trauma, abdominal trauma, and/or active intracranial bleeding,

Show all 14Show fewer

Anuric renal failure, previous bowel surgery and/or short gut syndrome,
Cannot be enterally fed within 24 hours of admission according to the admitting physician,
On extracorporeal membrane oxygenation (ECMO),
Expected survival <24 hours or limitations to aggressive ICU care (DNR),
Receiving active CPR when admitted to the PICU,
A pre-existing bronchopleural fistula,
Previously enrolled and randomized into this protocol,
Actively enrolled in another clinical trial which at the discretion of the PI would conflict with this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Arizona Medical Center
Tucson, Arizona, 85724-5073

Other trials in United States

About this study

Optimal delivery of nutritional support during critical illness is central to appropriate intensive care unit management, and yet fundamental gaps in knowledge exist regarding timing, route, dose, and type of nutritional support for critically ill infants and children. Understanding how to optimize nutritional support during pediatric critical illness is important because even brief periods of malnutrition in infancy result in permanent negative effects on long-term neurocognitive development. Optimized nutrition support is a way to improve morbidity for survivors of pediatric critical illness. Parenteral nutrition (PN) supplementation could improve long-term neurocognitive outcome for pediatric critical illness by preventing acute malnutrition, but has unknown effects on intestinal barrier function; a proposed mechanism for late sepsis and infectious complications during critical illness.

While randomized controlled trials (RCT) support early PN in premature infants and late PN in critically ill adults, the optimal time to begin PN is unknown for critically ill infants and children. Acute malnutrition may develop within 48 hours of admission in critically ill infants and children, and repleted energy stores are predictive of survival. And yet, due to concerns for PN-associated infectious morbidity, current PICU standard of care is to supplement with PN only in children who fail to enterally feed, as late as 7 days into their admission. Delays in nutrition may have long-term effects on cognitive outcome in older infants and children. In premature infants, PN begun within hours of birth results in improved 18-month neurocognitive outcome without an increase in infectious complications. An RCT is needed to determine if early PN in critically ill infants and children prevents acute malnutrition and improves short and long-term outcomes of PICU hospitalization.

The central hypothesis of this proposal is that optimized early protein and calorie delivery will improve nutritional outcomes and intestinal barrier function for critically ill infants and children. The overall purpose of this study is to evaluate the efficacy and safety of early PN as a supplement to enteral nutrition to improve nutritional delivery, nutritional outcomes, and intestinal barrier function for infants and children with acute respiratory failure who are mechanically ventilated in the pediatric intensive care unit.

Conditions: Acute Respiratory Failure With Hypoxia, Malnutrition
Being tested: Parenteral Nutrition
Medical subject headings: Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Parenteral NutritionDrug

Study groups in NCT01937884
Study group	Role	What they receive
Early Parenteral Nutrition	Experimental	Patients receive supplemental parenteral nutrition within 12 hours of enrollment. Titrated with enteral nutrition to achieve target goal calories and protein. Receives: Drug: Parenteral Nutrition
Late Parenteral Nutrition	Active comparator	Patients receive supplemental parenteral nutrition 96 hours after enrollment. Titrated with enteral nutrition to achieve target goal calories and protein. Receives: Drug: Parenteral Nutrition

What is being measured

The primary outcome is the main question the study is designed to answer.

Modified Prognostic Inflammatory and Nutritional Index (PINI)
The change day 0 to day 5 of the modified Prognostic Inflammatory and Nutritional Index (PINI) is a quantitative method to monitor the relation between markers of nutrition and acute phase proteins. It allows assessment of nutrition markers in the context of acute inflammation and in response to early enteral nutrition. A higher baseline PINI score indicates higher degree of inflammation. The modified PINI is calculated by the the ratio of (C-Reactive Protein(mg/dL) x Fibrinogen (mg/dL))/ (Transferrin (mg/dL) x Transthyretin (mg/dL)). The average change in the modified PINI from day 0 to day 5 critically ill children receiving early enteral nutrition is a decrease by 5.3 +/- 3.2 (mean +/- standard error of the mean) (Briassoulis et.al. Nutrition 2001). A larger negative number for the change from day 0 to day 5 indicates a greater degree of inflammation resolution.
Measured: Change in PINI from day 0 to day 5

Secondary outcomes (5)

Cumulative Percent of Daily Goal Calories Achieved
Evaluate percentage of cumulative goal calories achieved through parenteral and enteral routes in both study arms until patient exits study participation. Measure is calculated by (sum of kcal delivered over days of study participation/number of days in study).
Measured: baseline and daily through day 7
Plasma Intestinal Fatty Acid Binding Protein (I-FABP)
The percent change in plasma Intestinal Fatty Acid Binding Protein from baseline to study day 5, prior to late PN initiation
Measured: baseline and day 5
Plasma Citrulline
Evaluates absolute plasma citrulline concentration as a measure of functional enterocyte mass. A higher citrulline concentration indicates a higher functional enterocyte mass. Healthy children have an average citrulline concentration of 25 +/- 9 uMol/L. Assessed on day 0 and day 5, results reported for day 0 and 5. Outcome analysis on difference between treatment groups on day 5.
Measured: baseline and day 5
Plasma Claudin 3
As a measure of enterocyte tight junctions, calculate the percent change in plasma claudin 3 concentrations from baseline (day 0) and study day 5, prior to late PN administration.
Measured: baseline through hour 96
Gastrointestinal Permeability
Gastrointestinal permeability measured with the ratio of urinary recovery of lactulose and mannitol on day 5 of study participation. The range of values is generally reported as 0.02 to 2.2 with a higher value indicating greater gastrointestinal permeability. Values obtained on day 0 and day 5, day 5 reported.
Measured: day 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2013Aug 2018

First posted10 Sep 2013 (estimated)
Study startAug 2013
Primary completionAug 2018
Study completionAug 2018

Why it stopped: Unable to enroll patients

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute Respiratory Failure With HypoxiaStudies of the same condition, open and under way.
More trials run by University of ArizonaThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01937884
Sponsor's protocol ID: 13-0374
Other IDs: 5K12HD047349-09
Acronym: SuPPeR
Status last verified: Feb 2021
First submitted: 1 Sep 2013
Last updated: 3 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Automated Quantification of Radiologic Pulmonary Alteration During Acute Respiratory Failure: Application to the COVID-19 Pandemic
SARS-CoV-2 Infections, Respiratory Failure With Hypoxia
Recruiting
Awake Prone Positioning in Spontaneous Breathing Patients With Acute Hypoxic Respiratory Failure Due to Pneumonia
Acute Hypoxemic Respiratory Failure
Active, not recruitingObservational study
Weaning From High Flow Nasal Oxygen in Acute Respiratory Failure : a Target Trial Emulation
Respiratory Failure With Hypoxia, Respiratory Failure, ICU
RecruitingObservational study
PEEP in Patients With Acute Respiratory Failure
Acute Respiratory Failure With Hypoxia
Recruiting
Physiologic Effects of Continuous Positive Airway Pressure and High Flow Nasal Oxygenation in Patients with Acute Respiratory Distress Syndrome.
Acute Respiratory Distress Syndrome (ARDS), Acute Respiratory Failure with Hypoxia

All Acute Respiratory Failure With Hypoxia trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Supplemental Parenteral Nutrition in Pediatric Respiratory Failure
ClinicalTrials.gov ID: NCT01937884
Acronym / sponsor ID: SuPPeR / 13-0374
Conditions: Acute Respiratory Failure With Hypoxia, Malnutrition
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Unable to enroll patients
Enrolment: 18 participants (actual)
Lead sponsor: University of ArizonaUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: Aug 2013 (actual)
Primary completion: Aug 2018 (actual)
Study completion: Aug 2018 (actual)
First posted: 10 Sep 2013 (estimated)
Results: Posted 3 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Early Parenteral Nutrition	Experimental	Drug: Parenteral NutritionPatients receive supplemental parenteral nutrition within 12 hours of enrollment. Titrated with enteral nutrition to achieve target goal calories and protein.
Late Parenteral Nutrition	Active comparator	Drug: Parenteral NutritionPatients receive supplemental parenteral nutrition 96 hours after enrollment. Titrated with enteral nutrition to achieve target goal calories and protein.

Who may qualify

Ages: 1 month to 16 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Admitted to study hospital pediatric intensive care unit (PICU),
One month to 16 years of age,
Exhibits Acute Hypoxemic Respiratory Failure as defined as: PaO2/FiO2 ≤ 300 or SpO2/FiO2 ≤ 260, No evidence of cardiac dysfunction, Mechanically ventilated,
Require artificial nutrition,
Anticipate placement of central venous line within 24 hours of admission

Key exclusion criteria (14 listed)

Premature infants and neonates < 37 weeks corrected gestational age,
Transfer patient on an established enteral or parenteral nutritional regimen,
Known allergy to lactulose or mannitol,
Pregnant,
Admit BMI >30,

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
Parenteral Nutrition	Drug	Early Parenteral Nutrition, Late Parenteral Nutrition

Primary outcome

Modified Prognostic Inflammatory and Nutritional Index (PINI)
Time frame: Change in PINI from day 0 to day 5
The change day 0 to day 5 of the modified Prognostic Inflammatory and Nutritional Index (PINI) is a quantitative method to monitor the relation between markers of nutrition and acute phase proteins. It allows assessment of nutrition markers in the context of acute inflammation and in response to early enteral nutrition. A higher baseline PINI score indicates higher degree of inflammation. The modified PINI is calculated by the the ratio of (C-Reactive Protein(mg/dL) x Fibrinogen (mg/dL))/ (Transferrin (mg/dL) x Transthyretin (mg/dL)). The average change in the modified PINI from day 0 to day 5 critically ill children receiving early enteral nutrition is a decrease by 5.3 +/- 3.2 (mean +/- standard error of the mean) (Briassoulis et.al. Nutrition 2001). A larger negative number for the change from day 0 to day 5 indicates a greater degree of inflammation resolution.

5 secondary outcomes

Cumulative Percent of Daily Goal Calories Achieved
Time frame: baseline and daily through day 7
Plasma Intestinal Fatty Acid Binding Protein (I-FABP)
Time frame: baseline and day 5
Plasma Citrulline
Time frame: baseline and day 5
Plasma Claudin 3
Time frame: baseline through hour 96
Gastrointestinal Permeability
Time frame: day 5

Results and safety

Results posted to the registry on 3 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Early Parenteral Nutrition	7	6
Late Parenteral Nutrition	11	11

Primary outcome: Modified Prognostic Inflammatory and Nutritional Index (PINI)

Time frame: Change in PINI from day 0 to day 5. Mean (Standard Error). Unit: score on a scale

Measure	Early Parenteral Nutrition n = 4	Late Parenteral Nutrition n = 7
Value	-1.6 (1.0)	-3.2 (1.8)

Early Parenteral Nutrition vs Late Parenteral Nutrition: p = 0.57, Wilcoxon (Mann-Whitney)

Population analysed: Patients with central venous access and/or arterial access removed at study day 5 did not have blood drawn for PINI measurement. All patients with paired PINI values from day 0 and day 5 obtained are analyzed based on initial group assignment.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected over 14 days, from time of patient enrollment. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Early Parenteral Nutrition	0 of 7 (0%)	5 of 7 (71.4%)	2 of 7
Late Parenteral Nutrition	5 of 11 (45.5%)	6 of 11 (54.5%)	0 of 11

Limitations and caveats (from the sponsor): This study was discontinued early due to slow enrollment. The small study size limits interpretation of clinical and biochemical outcomes data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Acute Respiratory Failure With Hypoxia

Active, not recruiting
Automated Quantification of Radiologic Pulmonary Alteration During Acute Respiratory Failure: Application to the COVID-19 Pandemic
SARS-CoV-2 Infections, Respiratory Failure With Hypoxia
Recruiting
Awake Prone Positioning in Spontaneous Breathing Patients With Acute Hypoxic Respiratory Failure Due to Pneumonia
Acute Hypoxemic Respiratory Failure
Active, not recruitingObservational study
Weaning From High Flow Nasal Oxygen in Acute Respiratory Failure : a Target Trial Emulation
Respiratory Failure With Hypoxia, Respiratory Failure, ICU
RecruitingObservational study
PEEP in Patients With Acute Respiratory Failure
Acute Respiratory Failure With Hypoxia
Recruiting
Physiologic Effects of Continuous Positive Airway Pressure and High Flow Nasal Oxygenation in Patients with Acute Respiratory Distress Syndrome.
Acute Respiratory Distress Syndrome (ARDS), Acute Respiratory Failure with Hypoxia

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.

Katri V Typpo, MD, MPH principal investigator

University of Arizona

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Parenteral Nutrition in people with Acute Respiratory Failure With Hypoxia and Malnutrition, run by University of Arizona at 1 site 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 5 inclusion and 14 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: stopped early, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Modified Prognostic Inflammatory and Nutritional Index (PINI) (time frame: Change in PINI from day 0 to day 5). 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 NCT01937884.

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 3 Mar 2021.