Supplemental Parenteral Nutrition in Pediatric Respiratory Failure

Stopped early · Phase 2

Conditions studied: Acute Respiratory Failure With Hypoxia, Malnutrition

In brief

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.

Key facts

Study ID

NCT01937884

Run by

University of Arizona

People needed

18

Starts

2013-08-01

Expected to finish

2018-08-01

Last updated by the study team

2021-03-03

Who can join

Age: 0 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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,
• 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.

Where it is running

• University of Arizona Medical Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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