Supplemental Parenteral Nutrition in Pediatric Respiratory Failure
Condition: Acute Respiratory Failure With Hypoxia; Malnutrition
MeSH terms: Respiratory Insufficiency; Malnutrition; Hypoxia
Intervention: Parenteral Nutrition
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 18.0
Sex: All
Minimum age: 1 Month
Maximum age: 16 Years
Healthy volunteers: No

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.
    

Eligibility 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.