Supplemental Parenteral Nutrition in Pediatric Respiratory Failure
Status:
Terminated
Trial end date:
2018-08-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
University of Arizona
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)