Timing of Initiation of Parenteral Nutrition for Critically Ill Children (TPN)
Primary Purpose
Critical Illness
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
A randomized controlled open-label clinical trial.
Sponsored by
About this trial
This is an interventional other trial for Critical Illness focused on measuring Critically, Pediatric, Parenteral, Nutrition
Eligibility Criteria
Patients' eligibility inclusion criteria:
• Critically ill children admitted to PICU for various reasons and unable to receive their full caloric requirements through the enteral route will be eligible for this study.
Exclusion criteria:
- Included expected short PICU stay < 3 days e.g. Diabetic ketoacidosis;
- Age under 1 month or over 16 years.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Parenteral Nutrition for Critically Ill Children
Arm Description
Total Parenteral Nutrition for critically ill children
Outcomes
Primary Outcome Measures
Association of timing of Parental nutrition with Need for Mechanical ventilation and its duration.
Need for Mechanical ventilation and duration in days.
Secondary Outcome Measures
Association of timing of Parental nutrition with mortality ,Vasoactive infusion days, and Incidence of new infections. .
Secondary outcomes included: 1).PICU stay in days, 2).Duration of Vasoactive infusion in days; 3). Incidence of new infections; and 4). PICU mortality.
of new infections; and PICU mortality.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04693143
Brief Title
Timing of Initiation of Parenteral Nutrition for Critically Ill Children
Acronym
TPN
Official Title
Parenteral Nutrition for Critically Ill Children
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 15, 2021 (Anticipated)
Primary Completion Date
March 15, 2021 (Anticipated)
Study Completion Date
June 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Parenteral Nutrition (PN) is prescribed to children with a non functioning gut. Timing of initiation of PN for critically ill children is a hotly issue. Therefore investigators aim to determine the optimal timing of initiation of PN among these children.This is a randomized clinical trial will be conducted at a Pediatric Intensive Care Unit(PICU) in tertiary care hospital. 140 participants will be randomized to receive either early or late PN. The 1st group gives PN on the 1st day of PICU admissions while the 2nd group gives late PN on the 7th day. Under-nutrition children, early PN will start on the 1st day while late PN begins on 4th day of admission. The outcomes are assessment of mechanical ventilation duration, PICU length stay, and mortality.
Detailed Description
Participants and Methods:
This is a single-center; open-label randomized controlled trial will be performed at a Pediatric Intensive Care Unit (PICU) in tertiary care hospital . On admission, patients will be evaluated through history, clinical examination, and investigation.Basic investigations will include complete blood count, serum electrolytes, blood gas analysis, serum creatinine and liver function tests. The severity of the clinical condition upon admission will be determined by calculation of pediatric Sequential Organ Failure Assessment (pSOFA) score and Pediatric Risk of Mortality (PRISM) at the end of the first 24 hours. Patients will be randomized to receive either early or late parenteral nutrition. Early parenteral nutrition will be given in the 1st 24 hours of admission while late parenteral nutrition will be initiated on 7th day of admission. Randomization will be performed by using computer generated random numbers.The patients and the treating physicians will be not blinded to the type of parenteral fluids given. For children with moderate/severe under-nutrition, early parenteral nutrition will start on the 1st day while late parenteral nutrition will on 4th day of admission. This difference in timing of feeding is based on the fact that malnourished children have limited energy reserves and insufficient nutrition for 6 days might be too long a period compared with the case of well-nourished children. Parenteral nutrition consists of glucose, protein, electrolytes (sodium, potassium, calcium, magnesium, and phosphorus), trace elements, water soluble vitamins, and amino acid solutions.Lipid emulsions will be given . The nutritional status of patients will be carefully assessed. The admission weight and length/height will be recorded and a patient will be deemed to have under-nutrition if weight for length z-score is ≤ -2 SD. For children > 36 months, weight/age z-score ≤ -2 SD is used , instead, to define under-nutrition because measuring the height is difficult for critically ill children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
Critically, Pediatric, Parenteral, Nutrition
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A randomized controlled open-label clinical trial
Masking
None (Open Label)
Masking Description
A). Primary outcome for assessment of participants who need mechanical ventilation(MV) and MV duration.
B). Secondary outcomes will include assessment of participants accordingly, Pediatric Intensive Care Unit (PICU) stay , days of need for vasoacitive drugs infusion , incidence of new infections ,and PICU mortality.
Allocation
N/A
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Parenteral Nutrition for Critically Ill Children
Arm Type
Other
Arm Description
Total Parenteral Nutrition for critically ill children
Intervention Type
Other
Intervention Name(s)
A randomized controlled open-label clinical trial.
Intervention Description
This was a single-center; open-label randomized controlled trial performed at a Pediatric Intensive Care Unit (PICU) in tertiary care hospital
Primary Outcome Measure Information:
Title
Association of timing of Parental nutrition with Need for Mechanical ventilation and its duration.
Description
Need for Mechanical ventilation and duration in days.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Association of timing of Parental nutrition with mortality ,Vasoactive infusion days, and Incidence of new infections. .
Description
Secondary outcomes included: 1).PICU stay in days, 2).Duration of Vasoactive infusion in days; 3). Incidence of new infections; and 4). PICU mortality.
of new infections; and PICU mortality.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients' eligibility inclusion criteria:
• Critically ill children admitted to PICU for various reasons and unable to receive their full caloric requirements through the enteral route will be eligible for this study.
Exclusion criteria:
Included expected short PICU stay < 3 days e.g. Diabetic ketoacidosis;
Age under 1 month or over 16 years.
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
open-label randomized controlled trial performed at a Pediatric Intensive Care Unit (PICU) in tertiary care hospital
Learn more about this trial
Timing of Initiation of Parenteral Nutrition for Critically Ill Children
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