Timing of Initiation of Parenteral Nutrition for Critically Ill Children

Critical Illness Clinical Trial

— TPN  

Official title:

Parenteral Nutrition for Critically Ill Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04693143
• Other study ID #: 192119PED14.
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: June 15, 2021

Study information

• Verified date: March 2021
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: June 15, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness

Intervention

Other:
• A randomized controlled open-label clinical trial.
This was a single-center; open-label randomized controlled trial performed at a Pediatric Intensive Care Unit (PICU) in tertiary care hospital

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association of timing of Parental nutrition with Need for Mechanical ventilation and its duration.	Need for Mechanical ventilation and duration in days.	3 months
Secondary	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.	3 months