Supplemental Parenteral Nutrition in Pediatric Respiratory Failure (SuPPeR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01937884|
Recruitment Status : Recruiting
First Posted : September 10, 2013
Last Update Posted : March 22, 2018
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 or disease||Intervention/treatment||Phase|
|Acute Respiratory Failure With Hypoxia Malnutrition||Drug: Parenteral Nutrition||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Supplemental Parenteral Nutrition in Pediatric Respiratory Failure|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||August 2018|
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
- modified Prognostic Inflammatory and Nutritional Index (PINI) [ Time Frame: baseline and 5 days ]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.
- Percentage of daily goal calories achieved [ Time Frame: baseline and daily through day 7 ]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 ]
- serum Intestinal Fatty Acid Binding Protein (I-FABP) [ Time Frame: baseline through day 7 ]Intestinal Fatty Acid Binding Protein
- serum citrulline [ Time Frame: baseline through day 7 ]Evaluates functional enterocyte mass
- serum claudin 3 [ Time Frame: baseline through day 7 ]Enterocyte tight junction proteins
- gastrointestinal permeability [ Time Frame: baseline and day 5 ]
- incidence of hospital acquired infections [ Time Frame: until hospital discharge or day 28 if still hospitalized ]
- dialysis utilization [ Time Frame: until hospital discharge or day 28 if still hospitalized ]
- all cause mortality [ Time Frame: 28 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01937884
|Contact: Katri V. Typpo, MD, MPHfirstname.lastname@example.org|
|Contact: Connor Kelleyemail@example.com|
|United States, Arizona|
|University of Arizona Medical Center||Recruiting|
|Tucson, Arizona, United States, 85724-5073|
|Principal Investigator: Katri V. Typpo, MD, MPH|
|Principal Investigator:||Katri V Typpo, MD, MPH||University of Arizona|