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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

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.


Condition or disease Intervention/treatment Phase
Acute Respiratory Failure With Hypoxia Malnutrition Drug: Parenteral Nutrition Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Supplemental Parenteral Nutrition in Pediatric Respiratory Failure
Actual Study Start Date : August 2013
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.
Drug: Parenteral Nutrition



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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

  3. 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.

  4. 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.

  5. 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.


Other Outcome Measures:
  1. 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.

  2. 28-day Mortality [ Time Frame: 28 days ]
    Death of a study patient do to any cause measured up to 28 days after study enrollment.



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01937884


Locations
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United States, Arizona
University of Arizona Medical Center
Tucson, Arizona, United States, 85724-5073
Sponsors and Collaborators
University of Arizona
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Katri V Typpo, MD, MPH University of Arizona
  Study Documents (Full-Text)

Documents provided by Katri Typpo, University of Arizona:
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Responsible Party: Katri Typpo, Assistant Professor, University of Arizona
ClinicalTrials.gov Identifier: NCT01937884    
Other Study ID Numbers: 13-0374
5K12HD047349-09 ( U.S. NIH Grant/Contract )
First Posted: September 10, 2013    Key Record Dates
Results First Posted: March 3, 2021
Last Update Posted: March 3, 2021
Last Verified: February 2021
Additional relevant MeSH terms:
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Respiratory Insufficiency
Malnutrition
Hypoxia
Respiration Disorders
Respiratory Tract Diseases
Nutrition Disorders
Signs and Symptoms, Respiratory