Clinical trial NCT01937884: Supplemental Parenteral Nutrition in Pediatric Respiratory Failure
Official title: Supplemental Parenteral Nutrition in Pediatric Respiratory Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Respiratory Failure With Hypoxia
Malnutrition
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2013-09-10
Enrollment: 18
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Modified Prognostic Inflammatory and Nutritional Index (PINI)
timeFrame: Change in PINI from day 0 to day 5
Secondary outcomes:
measure: Cumulative Percent of Daily Goal Calories Achieved
timeFrame: baseline and daily through day 7
measure: Plasma Intestinal Fatty Acid Binding Protein (I-FABP)
timeFrame: baseline and day 5
measure: Plasma Citrulline
timeFrame: baseline and day 5
measure: Plasma Claudin 3
timeFrame: baseline through hour 96
measure: Gastrointestinal Permeability
timeFrame: day 5
Other outcomes:
measure: Number of Participants With Hospital-Acquired Infections
timeFrame: until hospital discharge or day 28 if still hospitalized
measure: 28-day Mortality
timeFrame: 28 days
Locations:
city: Tucson
country: United States
facility: University of Arizona Medical Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: Katri V Typpo, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: