Improvement Project To Optimizing Nutrition With Higher Protein and Calorie Pediatric Tube Feeding

Critically Ill Children Clinical Trial

Official title:

An Improvement Project Towards Optimizing Nutrition Intervention With a Higher Protein and Calorie Pediatric Tube Feeding Formula

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03017664
• Other study ID #: 16.04.US.HCN
• Status: Completed
• Start date: January 15, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2020
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This quality improvement project will include a practice change based on national guidelines for the nutritional management of PICU patients.

Description:

This quality improvement project will include a practice change based on national guidelines for the nutritional management of PICU patients. The primary aim of this quality improvement project is to better meet protein needs of ICU critically ill children

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 13 Years

Eligibility

Inclusion Criteria:

• Children aged 1-18 years old with enteral feeding access and anticipated to be fed for 5 days

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill Children

Intervention

Other:
• Peptide-based enteral formula
Peptide-based, higher protein and higher calorie enteral formula
• Retrospective review of enteral tube feeding formula
Enteral formula tube feeding will be retrospectively reviewed

Locations

Country	Name	City	State
United States	The University of Chicago, Comer Children's Hospital	Chicago	Illinois
United States	Le Bonheur Children's Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Protein modular	yes/no; if yes, dose (g/mL) and schedule	5 days
Other	Enteral feeding interruptions	yes/no; if yes, reason for interruption	5 days
Other	Diarrhea	yes/no; if yes, frequency in 24 hour period	5 days
Other	Vomiting	yes/no; if yes, frequency in 24 hour period	5 days
Other	Elevated gastric residuals	yes/no; if yes, amount (mL) in 24 hour period	5 days
Other	Abdominal distention/pain	yes/no	5 days
Primary	Enteral formula volume	Daily total formula volume (mL) delivered	5 days