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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
Menoufia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Critical Illness focused on measuring Critically, Pediatric, Parenteral, Nutrition

Eligibility Criteria

1 Month - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 24, 2020
    Last Updated
    March 3, 2021
    Sponsor
    Menoufia University
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    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

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    Timing of Initiation of Parenteral Nutrition for Critically Ill Children

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