Timing of Initiation of Parenteral Nutrition for Critically Ill Children

NCT04693143 | Unknown DMC

• 1 other identifier: 192119PED14.
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Critical Illness

Keywords

Critically; Pediatric; Parenteral; Nutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Association of timing of Parental nutrition with mortality ,Vasoactive infusion days, and Incidence of new infections. .

  3 months

Study Arms (1)

Parenteral Nutrition for Critically Ill Children

OTHER

Total Parenteral Nutrition for critically ill children

Other: A randomized controlled open-label clinical trial.

Interventions

A randomized controlled open-label clinical trial. OTHER

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

Parenteral Nutrition for Critically Ill Children

Eligibility Criteria

• Age: 1 Month - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Included expected short PICU stay \< 3 days e.g. Diabetic ketoacidosis;
• Age under 1 month or over 16 years.

Sponsors & Collaborators

• Menoufia University: lead

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Pediatrics

Model Details: A randomized controlled open-label clinical trial

Study Record Dates

• First Submitted: December 24, 2020
• First Posted: January 5, 2021
• Study Start: March 15, 2021
• Primary Completion: March 15, 2021
• Study Completion: June 15, 2021
• Last Updated: March 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share