Supplemental Parenteral Nutrition in Pediatric Respiratory Failure (SuPPeR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Arizona
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Katri Typpo, University of Arizona
ClinicalTrials.gov Identifier:
NCT01937884
First received: September 1, 2013
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Acute Respiratory Failure With Hypoxia
Malnutrition
Drug: Parenteral Nutrition
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Supplemental Parenteral Nutrition in Pediatric Respiratory Failure

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • modified Prognostic Inflammatory and Nutritional Index (PINI) [ Time Frame: baseline and 5 days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percentage of daily goal calories achieved [ Time Frame: baseline and daily through day 7 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • serum Intestinal Fatty Acid Binding Protein (I-FABP) [ Time Frame: baseline through day 7 ] [ Designated as safety issue: No ]
    Intestinal Fatty Acid Binding Protein

  • serum citrulline [ Time Frame: baseline through day 7 ] [ Designated as safety issue: No ]
    Evaluates functional enterocyte mass

  • serum claudin 3 [ Time Frame: baseline through day 7 ] [ Designated as safety issue: No ]
    Enterocyte tight junction proteins

  • gastrointestinal permeability [ Time Frame: baseline and day 5 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • incidence of hospital acquired infections [ Time Frame: until hospital discharge or day 28 if still hospitalized ] [ Designated as safety issue: Yes ]
  • dialysis utilization [ Time Frame: until hospital discharge or day 28 if still hospitalized ] [ Designated as safety issue: Yes ]
  • all cause mortality [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: August 2013
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   1 Month to 16 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01937884

Contacts
Contact: Katri V. Typpo, MD, MPH 5206265485 ktyppo@peds.arizona.edu
Contact: Jendar J. Deschenes, MPH 5206262610 jjd@peds.arizona.edu

Locations
United States, Arizona
University of Arizona Medical Center Recruiting
Tucson, Arizona, United States, 85724-5073
Principal Investigator: Katri V. Typpo, MD, MPH         
Sponsors and Collaborators
University of Arizona
Investigators
Principal Investigator: Katri V Typpo, MD, MPH University of Arizona
  More Information

No publications provided

Responsible Party: Katri Typpo, Assistant Professor, University of Arizona
ClinicalTrials.gov Identifier: NCT01937884     History of Changes
Other Study ID Numbers: 13-0374, 5K12HD047349-09
Study First Received: September 1, 2013
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders
Anoxia
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Signs and Symptoms, Respiratory
Signs and Symptoms
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders

ClinicalTrials.gov processed this record on August 20, 2014