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Supplemental Parenteral Nutrition in Pediatric Respiratory Failure (SuPPeR)

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ClinicalTrials.gov Identifier: NCT01937884
Recruitment Status : Terminated (Unable to enroll patients)
First Posted : September 10, 2013
Results First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Katri Typpo, University of Arizona

Tracking Information
First Submitted Date  ICMJE September 1, 2013
First Posted Date  ICMJE September 10, 2013
Results First Submitted Date  ICMJE January 25, 2021
Results First Posted Date  ICMJE March 3, 2021
Last Update Posted Date March 3, 2021
Actual Study Start Date  ICMJE August 2013
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2021)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 4, 2013)
modified Prognostic Inflammatory and Nutritional Index (PINI) [ Time Frame: baseline and 5 days ]
The change over time of the modified PINI evaluates sequential biochemical indices of nutrition while controlling for changes in the magnitude of the acute phase reaction. The modified PINI incorporates the ratio of C-Reactive Protein and fibrinogen to transferrin and albumin.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2021)
  • Cumulative Percent of Daily Goal Calories Achieved [ Time Frame: baseline and daily through day 7 ]
    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).
  • Plasma Intestinal Fatty Acid Binding Protein (I-FABP) [ Time Frame: baseline and day 5 ]
    The percent change in plasma Intestinal Fatty Acid Binding Protein from baseline to study day 5, prior to late PN initiation
  • Plasma Citrulline [ Time Frame: baseline and day 5 ]
    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.
  • Plasma Claudin 3 [ Time Frame: baseline through hour 96 ]
    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.
  • Gastrointestinal Permeability [ Time Frame: day 5 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2013)
  • Percentage of daily goal calories achieved [ Time Frame: baseline and daily through day 7 ]
    Evaluate percentage of goal calories achieved through parenteral and enteral routes in both study arms.
  • Organ failure free days [ Time Frame: daily through discharge or up to day 28 ]
  • serum Intestinal Fatty Acid Binding Protein (I-FABP) [ Time Frame: baseline through day 7 ]
    Intestinal Fatty Acid Binding Protein
  • serum citrulline [ Time Frame: baseline through day 7 ]
    Evaluates functional enterocyte mass
  • serum claudin 3 [ Time Frame: baseline through day 7 ]
    Enterocyte tight junction proteins
  • gastrointestinal permeability [ Time Frame: baseline and day 5 ]
Current Other Pre-specified Outcome Measures
 (submitted: February 11, 2021)
  • Number of Participants With Hospital-Acquired Infections [ Time Frame: until hospital discharge or day 28 if still hospitalized ]
    Record any hospital-defined hospital acquired infections through day 28 in all study participants.
  • 28-day Mortality [ Time Frame: 28 days ]
    Death of a study patient do to any cause measured up to 28 days after study enrollment.
Original Other Pre-specified Outcome Measures
 (submitted: September 4, 2013)
  • incidence of hospital acquired infections [ Time Frame: until hospital discharge or day 28 if still hospitalized ]
  • dialysis utilization [ Time Frame: until hospital discharge or day 28 if still hospitalized ]
  • all cause mortality [ Time Frame: 28 days ]
 
Descriptive Information
Brief Title  ICMJE Supplemental Parenteral Nutrition in Pediatric Respiratory Failure
Official Title  ICMJE Supplemental Parenteral Nutrition in Pediatric Respiratory Failure
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Respiratory Failure With Hypoxia
  • Malnutrition
Intervention  ICMJE Drug: Parenteral Nutrition
Study Arms  ICMJE
  • Experimental: Early Parenteral Nutrition
    Patients receive supplemental parenteral nutrition within 12 hours of enrollment. Titrated with enteral nutrition to achieve target goal calories and protein.
    Intervention: Drug: Parenteral Nutrition
  • Active Comparator: Late Parenteral Nutrition
    Patients receive supplemental parenteral nutrition 96 hours after enrollment. Titrated with enteral nutrition to achieve target goal calories and protein.
    Intervention: Drug: Parenteral Nutrition
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 2, 2020)
18
Original Estimated Enrollment  ICMJE
 (submitted: September 4, 2013)
80
Actual Study Completion Date  ICMJE August 2018
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  1. Premature infants and neonates < 37 weeks corrected gestational age,
  2. Transfer patient on an established enteral or parenteral nutritional regimen,
  3. Known allergy to lactulose or mannitol,
  4. Pregnant,
  5. Admit BMI >30,
  6. Thoracic trauma, abdominal trauma, and/or active intracranial bleeding,
  7. Anuric renal failure, previous bowel surgery and/or short gut syndrome,
  8. Cannot be enterally fed within 24 hours of admission according to the admitting physician,
  9. On extracorporeal membrane oxygenation (ECMO),
  10. Expected survival <24 hours or limitations to aggressive ICU care (DNR),
  11. Receiving active CPR when admitted to the PICU,
  12. A pre-existing bronchopleural fistula,
  13. Previously enrolled and randomized into this protocol,
  14. Actively enrolled in another clinical trial which at the discretion of the PI would conflict with this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01937884
Other Study ID Numbers  ICMJE 13-0374
5K12HD047349-09 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Katri Typpo, University of Arizona
Study Sponsor  ICMJE University of Arizona
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Katri V Typpo, MD, MPH University of Arizona
PRS Account University of Arizona
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP