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Supplemental Parenteral Nutrition in Pediatric Respiratory Failure (SuPPeR)

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ClinicalTrials.gov Identifier: NCT01937884
Recruitment Status : Terminated (Unable to enroll patients)
First Posted : September 10, 2013
Results First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Katri Typpo, University of Arizona

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Acute Respiratory Failure With Hypoxia
Malnutrition
Intervention Drug: Parenteral Nutrition
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Early Parenteral Nutrition Late Parenteral Nutrition
Hide Arm/Group Description Patients receive supplemental parenteral nutrition within 12 hours of enrollment. Titrated with enteral nutrition to achieve target goal calories and protein over the one week study period. Patients receive supplemental parenteral nutrition 96 hours after enrollment if meeting < 80% of caloric goals with enteral nutrition alone. Titrated with enteral nutrition to achieve target goal calories and protein over the one week study period.
Period Title: Overall Study
Started 7 11
Completed 6 11
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title Early Parenteral Nutrition Late Parenteral Nutrition Total
Hide Arm/Group Description Patients receive supplemental parenteral nutrition within 12 hours of enrollment. Titrated with enteral nutrition to achieve target goal calories and protein over the one week study period. Patients receive supplemental parenteral nutrition 96 hours after enrollment if meeting < 80% of caloric goals with enteral nutrition alone. Titrated with enteral nutrition to achieve target goal calories and protein over the one week study period. Total of all reporting groups
Overall Number of Baseline Participants 7 11 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 7 participants 11 participants 18 participants
1.4
(0.4 to 4.3)
1.1
(0.4 to 6.0)
1.3
(0.4 to 4.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 11 participants 18 participants
Female
4
  57.1%
6
  54.5%
10
  55.6%
Male
3
  42.9%
5
  45.5%
8
  44.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 11 participants 18 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  14.3%
0
   0.0%
1
   5.6%
White
6
  85.7%
9
  81.8%
15
  83.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
2
  18.2%
2
  11.1%
BMI z score   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Z score
Number Analyzed 7 participants 11 participants 18 participants
-.73
(-1.7 to 0.2)
-.9
(-1.2 to -0.03)
-0.9
(-1.7 to 0.21)
[1]
Measure Description: The BMI Z-Score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. BMI Z-score cut-points of < - 2.0, > 1.0, > 2.0, > 3.0 define wasted, at risk of overweight, overweight and obese, respectively. BMI z scores were calculated used CDC growth charts for children 2 years of age and older. For children under 2 years of age the weight for age Z score is reported.
PELOD-2 score   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 7 participants 11 participants 18 participants
8
(6 to 9)
7
(5 to 9)
7.5
(6 to 9)
[1]
Measure Description: The Pediatric Logistic Organ Dysfunction-2 (PELOD-2) score allows assessment of the severity of organ dysfunction on a continuous scale. The score incorporates assessment of 5 organ system dysfunction (Cardiovascular, Neurologic, Respiratory, Hematologic, and Renal). Component scores for each organ system can be calculated, only the composite score which reflects baseline severity of illness and organ dysfunction is reported in our study. The minimum PELOD-2 score is 0 and the maximum is 33. A higher PELOD-2 score indicates a higher probability of death.
1.Primary Outcome
Title Modified Prognostic Inflammatory and Nutritional Index (PINI)
Hide Description The change day 0 to day 5 of the modified Prognostic Inflammatory and Nutritional Index (PINI) is a quantitative method to monitor the relation between markers of nutrition and acute phase proteins. It allows assessment of nutrition markers in the context of acute inflammation and in response to early enteral nutrition. A higher baseline PINI score indicates higher degree of inflammation. The modified PINI is calculated by the the ratio of (C-Reactive Protein(mg/dL) x Fibrinogen (mg/dL))/ (Transferrin (mg/dL) x Transthyretin (mg/dL)). The average change in the modified PINI from day 0 to day 5 critically ill children receiving early enteral nutrition is a decrease by 5.3 +/- 3.2 (mean +/- standard error of the mean) (Briassoulis et.al. Nutrition 2001). A larger negative number for the change from day 0 to day 5 indicates a greater degree of inflammation resolution.
Time Frame Change in PINI from day 0 to day 5
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with central venous access and/or arterial access removed at study day 5 did not have blood drawn for PINI measurement. All patients with paired PINI values from day 0 and day 5 obtained are analyzed based on initial group assignment.
Arm/Group Title Early Parenteral Nutrition Late Parenteral Nutrition
Hide Arm/Group Description:

Patients receive supplemental parenteral nutrition within 12 hours of enrollment. Titrated with enteral nutrition to achieve target goal calories and protein.

Parenteral Nutrition

Patients receive supplemental parenteral nutrition 96 hours after enrollment. Titrated with enteral nutrition to achieve target goal calories and protein.

Parenteral Nutrition

Overall Number of Participants Analyzed 4 7
Mean (Standard Error)
Unit of Measure: score on a scale
-1.6  (1.0) -3.2  (1.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Parenteral Nutrition, Late Parenteral Nutrition
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.57
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Cumulative Percent of Daily Goal Calories Achieved
Hide Description Evaluate percentage of cumulative goal calories achieved through parenteral and enteral routes in both study arms until patient exits study participation. Measure is calculated by (sum of kcal delivered over days of study participation/number of days in study).
Time Frame baseline and daily through day 7
Hide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled had daily nutrition data collected until end of study participation.
Arm/Group Title Early Parenteral Nutrition Late Parenteral Nutrition
Hide Arm/Group Description:
Patients receive supplemental parenteral nutrition within 12 hours of enrollment. Titrated with enteral nutrition to achieve target goal calories and protein over the one week study period.
Patients receive supplemental parenteral nutrition 96 hours after enrollment if meeting < 80% of caloric goals with enteral nutrition alone. Titrated with enteral nutrition to achieve target goal calories and protein over the one week study period.
Overall Number of Participants Analyzed 7 11
Median (Inter-Quartile Range)
Unit of Measure: percent of goal kcal/day
103.8
(98.5 to 110.2)
103.4
(86.4 to 110.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Parenteral Nutrition, Late Parenteral Nutrition
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Plasma Intestinal Fatty Acid Binding Protein (I-FABP)
Hide Description The percent change in plasma Intestinal Fatty Acid Binding Protein from baseline to study day 5, prior to late PN initiation
Time Frame baseline and day 5
Hide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled in the study with IFABP results obtained at baseline and hour 96, analyzed in initial assigned groups.
Arm/Group Title Early Parenteral Nutrition Late Parenteral Nutrition
Hide Arm/Group Description:
Patients receive supplemental parenteral nutrition within 12 hours of enrollment. Titrated with enteral nutrition to achieve target goal calories and protein over the one week study period.
Patients receive supplemental parenteral nutrition 96 hours after enrollment if meeting < 80% of caloric goals with enteral nutrition alone. Titrated with enteral nutrition to achieve target goal calories and protein over the one week study period.
Overall Number of Participants Analyzed 5 8
Median (Inter-Quartile Range)
Unit of Measure: percent change
2.11
(-35.9 to 28.3)
-25
(-47.9 to 8.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Parenteral Nutrition, Late Parenteral Nutrition
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method t-test, 2 sided
Comments Student's t-test on log-transformed change in IFABP.
4.Secondary Outcome
Title Plasma Citrulline
Hide Description Evaluates absolute plasma citrulline concentration as a measure of functional enterocyte mass. A higher citrulline concentration indicates a higher functional enterocyte mass. Healthy children have an average citrulline concentration of 25 +/- 9 uMol/L. Assessed on day 0 and day 5, results reported for day 0 and 5. Outcome analysis on difference between treatment groups on day 5.
Time Frame baseline and day 5
Hide Outcome Measure Data
Hide Analysis Population Description
Citrulline concentrations obtained for patients with plasma samples available for analysis on study day 0 and 5
Arm/Group Title Early Parenteral Nutrition Late Parenteral Nutrition
Hide Arm/Group Description:
Patients receive supplemental parenteral nutrition within 12 hours of enrollment. Titrated with enteral nutrition to achieve target goal calories and protein over the one week study period.
Patients receive supplemental parenteral nutrition 96 hours after enrollment if meeting < 80% of caloric goals with enteral nutrition alone. Titrated with enteral nutrition to achieve target goal calories and protein over the one week study period.
Overall Number of Participants Analyzed 7 11
Median (Inter-Quartile Range)
Unit of Measure: umoL per Liter
day 0 Number Analyzed 7 participants 11 participants
10
(8.6 to 14.8)
8
(4.7 to 11)
day 5 Number Analyzed 5 participants 8 participants
19.4
(19 to 32.5)
14.5
(11.1 to 20.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Parenteral Nutrition, Late Parenteral Nutrition
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method t-test, 2 sided
Comments Student's t-test on log-transformed citrulline concentration on study day 5, by treatment group
5.Secondary Outcome
Title Plasma Claudin 3
Hide Description As a measure of enterocyte tight junctions, calculate the percent change in plasma claudin 3 concentrations from baseline (day 0) and study day 5, prior to late PN administration.
Time Frame baseline through hour 96
Hide Outcome Measure Data
Hide Analysis Population Description
Included all patients with claudin 3 plasma concentrations reported at hour zero and 96, analyzed in groups as initially assigned.
Arm/Group Title Early Parenteral Nutrition Late Parenteral Nutrition
Hide Arm/Group Description:
Patients receive supplemental parenteral nutrition within 12 hours of enrollment. Titrated with enteral nutrition to achieve target goal calories and protein over the one week study period.
Patients receive supplemental parenteral nutrition 96 hours after enrollment if meeting < 80% of caloric goals with enteral nutrition alone. Titrated with enteral nutrition to achieve target goal calories and protein over the one week study period.
Overall Number of Participants Analyzed 5 8
Median (Inter-Quartile Range)
Unit of Measure: percent change
29.8
(11.7 to 53.6)
111.7
(-8.8 to 224.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Parenteral Nutrition, Late Parenteral Nutrition
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.43
Comments [Not Specified]
Method t-test, 2 sided
Comments Student's t-test on log-transformed percent change of claudin 3
6.Secondary Outcome
Title Gastrointestinal Permeability
Hide Description Gastrointestinal permeability measured with the ratio of urinary recovery of lactulose and mannitol on day 5 of study participation. The range of values is generally reported as 0.02 to 2.2 with a higher value indicating greater gastrointestinal permeability. Values obtained on day 0 and day 5, day 5 reported.
Time Frame day 5
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis of lactulose and mannitol urinary concentrations performed on all patients who received the lactulose and mannitol study test and with urinary samples obtained on day 5.
Arm/Group Title Early Parenteral Nutrition Late Parenteral Nutrition
Hide Arm/Group Description:
Patients receive supplemental parenteral nutrition within 12 hours of enrollment. Titrated with enteral nutrition to achieve target goal calories and protein over the one week study period.
Patients receive supplemental parenteral nutrition 96 hours after enrollment if meeting < 80% of caloric goals with enteral nutrition alone. Titrated with enteral nutrition to achieve target goal calories and protein over the one week study period.
Overall Number of Participants Analyzed 5 8
Median (Inter-Quartile Range)
Unit of Measure: ratio
0.15
(0.13 to 0.78)
0.17
(0.13 to 0.24)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Parenteral Nutrition, Late Parenteral Nutrition
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.88
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
7.Other Pre-specified Outcome
Title Number of Participants With Hospital-Acquired Infections
Hide Description Record any hospital-defined hospital acquired infections through day 28 in all study participants.
Time Frame until hospital discharge or day 28 if still hospitalized
Hide Outcome Measure Data
Hide Analysis Population Description
All study participants
Arm/Group Title Early Parenteral Nutrition Late Parenteral Nutrition
Hide Arm/Group Description:
Patients receive supplemental parenteral nutrition within 12 hours of enrollment. Titrated with enteral nutrition to achieve target goal calories and protein over the one week study period.
Patients receive supplemental parenteral nutrition 96 hours after enrollment if meeting < 80% of caloric goals with enteral nutrition alone. Titrated with enteral nutrition to achieve target goal calories and protein over the one week study period.
Overall Number of Participants Analyzed 7 11
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   9.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Parenteral Nutrition, Late Parenteral Nutrition
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.43
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
8.Other Pre-specified Outcome
Title 28-day Mortality
Hide Description Death of a study patient do to any cause measured up to 28 days after study enrollment.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Determined for all study participants.
Arm/Group Title Early Parenteral Nutrition Late Parenteral Nutrition
Hide Arm/Group Description:
Patients receive supplemental parenteral nutrition within 12 hours of enrollment. Titrated with enteral nutrition to achieve target goal calories and protein over the one week study period.
Patients receive supplemental parenteral nutrition 96 hours after enrollment if meeting < 80% of caloric goals with enteral nutrition alone. Titrated with enteral nutrition to achieve target goal calories and protein over the one week study period.
Overall Number of Participants Analyzed 7 11
Measure Type: Count of Participants
Unit of Measure: Participants
2
  28.6%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Parenteral Nutrition, Late Parenteral Nutrition
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame Adverse event data were collected over 14 days, from time of patient enrollment
Adverse Event Reporting Description Adverse event reporting follows the clinicaltrials.gov definitions and includes all-cause mortality, serious adverse events, and other adverse events.
 
Arm/Group Title Early Parenteral Nutrition Late Parenteral Nutrition
Hide Arm/Group Description Patients receive supplemental parenteral nutrition within 12 hours of enrollment. Titrated with enteral nutrition to achieve target goal calories and protein over the one week study period. Patients receive supplemental parenteral nutrition 96 hours after enrollment if meeting < 80% of caloric goals with enteral nutrition alone. Titrated with enteral nutrition to achieve target goal calories and protein over the one week study period.
All-Cause Mortality
Early Parenteral Nutrition Late Parenteral Nutrition
Affected / at Risk (%) Affected / at Risk (%)
Total   2/7 (28.57%)      0/11 (0.00%)    
Hide Serious Adverse Events
Early Parenteral Nutrition Late Parenteral Nutrition
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      5/11 (45.45%)    
Blood and lymphatic system disorders     
Deep vein thrombosis  [1]  0/7 (0.00%)  0 3/11 (27.27%)  3
Gastrointestinal disorders     
Aspiration of gastric contents  [2]  0/7 (0.00%)  0 1/11 (9.09%)  1
Infections and infestations     
Hospital-Acquired infection  [3]  0/7 (0.00%)  0 1/11 (9.09%)  1
Indicates events were collected by systematic assessment
[1]
Identification of a deep vein thrombosis by ultrasound imaging
[2]
Aspiration event as determined by the Clinical team
[3]
Hospital-determined hospital acquired infections
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Early Parenteral Nutrition Late Parenteral Nutrition
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/7 (71.43%)      6/11 (54.55%)    
Metabolism and nutrition disorders     
Hyperglycemia  [1]  0/7 (0.00%)  0 1/11 (9.09%)  1
Respiratory, thoracic and mediastinal disorders     
Desaturation < 85%  [2]  5/7 (71.43%)  10 5/11 (45.45%)  9
Indicates events were collected by systematic assessment
[1]
Glucose value >200 mg/dL
[2]
Desaturation event with SaO2 < 85%
This study was discontinued early due to slow enrollment. The small study size limits interpretation of clinical and biochemical outcomes data.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Katri Typpo
Organization: University of Arizona
Phone: 5206265485
EMail: ktyppo@email.arizona.edu
Layout table for additonal information
Responsible Party: Katri Typpo, University of Arizona
ClinicalTrials.gov Identifier: NCT01937884    
Other Study ID Numbers: 13-0374
5K12HD047349-09 ( U.S. NIH Grant/Contract )
First Submitted: September 1, 2013
First Posted: September 10, 2013
Results First Submitted: January 25, 2021
Results First Posted: March 3, 2021
Last Update Posted: March 3, 2021