Review of Enteral Formulas in Children

• Sponsor: Nestlé (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT04247269
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Actual Duration (Months): 21.4
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

Retrospective review of nutrition enteral formula data documented in medical records.

Condition or Disease	Intervention/Treatment	Phase
Enteral Feeding Intolerance; Tube Feeding; Nutrition Disorder, Child	Other: Enteral Tube Feeding

Detailed Description

This is a retrospective review to assess nutrition (calorie and protein) intake of enteral formula data documented in medical records of patients that consumed enteral tube feeding formulas at home.

Study Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Retrospective Review of Enteral Formulas in Medically Complex Children
• Actual Study Start Date: Aug 21, 2020
• Actual Primary Completion Date: Jun 2, 2022
• Actual Study Completion Date: Jun 2, 2022

Arms and Interventions

Arm	Intervention/Treatment
Enteral formula standard Children fed an intact protein formula	Other: Enteral Tube Feeding; Enteral tube feeding
Enteral formula semi-elemental Children fed a semi-elemental protein formula	Other: Enteral Tube Feeding; Enteral tube feeding

Outcome Measures

Primary Outcome Measures

1. Nutrition Intake [12 months]

   Assessment of enteral formula calorie and protein intake compared to nutrition prescription

Secondary Outcome Measures

1. Body weight [12 months]

   Weight in kilograms

2. Length/height [12 months]

   Length/height (based on age) in centimeters

3. Formula volume consumption [12 months]

   Assessment of enteral formula volume compared to nutrition prescription

4. Stool frequency [12 months]

   Number of stools reported in medical record

5. Ventilator status [12 months]

   Assessment of ventilator change; extubated or continued

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Minimum 12 months enteral feeding

• History of enteral feeding with intact or semi-elemental formula

Exclusion Criteria:

• Medical records lacking enteral nutrition feeding use

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Central Ohio Specialty Care	Columbus	Ohio	United States	43228

Sponsors and Collaborators

• Nestlé

Investigators

• Study Director: Krysmaru AraujoTorres, MD, Nestlé

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nestlé
• ClinicalTrials.gov Identifier: NCT04247269
• Other Study ID Numbers: 19.02.US.HCN
• First Posted: Jan 30, 2020
• Last Update Posted: Jun 9, 2022
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Nutrition Disorders; Child Nutrition Disorders

Study Results

No Results Posted as of Jun 9, 2022