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Efficacy and Safety of the Algorithm for Enteral Nutrition Support

Primary Purpose

Nutrition Disorder, Child

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
intervention group
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Nutrition Disorder, Child

Eligibility Criteria

1 Day - 6 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

weight-for-age of z-score <-2; or length-for-age of z score <-2; or weight-for-length of z score <-2

Exclusion Criteria:

Any patient with congenital genetic metabolic diseases

Sites / Locations

  • Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

The patients' nutrition were supported according the the algorithm of the enteral nutrition.

The patients' nutrition were supported according the prescription of the physicians and dietician in our hospital.

Outcomes

Primary Outcome Measures

Malnutrition recovery
Malnutrition was assessed as recovering from malnutrition

Secondary Outcome Measures

Feeding intolerance
According to the criteria established by the American Academy of Pediatrics in 2003, the following symptoms are diagnosed as feeding intolerance: severe abdominal distension or discoloration; Signs of intestinal perforation; Obvious blood stool; Gastric retention ≥ 25% of the total amount after 2 to 3 feeding intervals; Bile reflux or vomiting; Severe apnea or bradycardia; Severe cardiopulmonary insufficiency; Apnea: Cessation of breathing for ≥20 seconds, or cessation of breathing accompanied by a decrease in SpO2.

Full Information

First Posted
April 4, 2017
Last Updated
October 25, 2020
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04609358
Brief Title
Efficacy and Safety of the Algorithm for Enteral Nutrition Support
Official Title
Efficacy and Safety of the Implementation of an Algorithm for Enteral Nutrition Support Compared With Traditional Practice in Children With Congenital Heart Disease: Randomized Clinical Trial, Simple Blind.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

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
The purpose of this trial is to evaluate the efficacy and safety of the implementation of an algorithm for enteral nutrition support compared with usual standard practice in children with malnutrition status with congenital heart disease
Detailed Description
In many developing countries, pediatric cardiac programs are not fully established, and nutrition support algorithm is lack. Therefore, this study aimed to evaluate the the efficacy and safety of the implementation of an algorithm for enteral nutrition support compared with usual standard practice in children with malnutrition status with congenital heart disease. The usual standard practice for feeding often interrupted by retention in the gut and then choose the parenteral nutrition support especially in the patients with unstable hemodynamic status. Actually tiny and continuous feeding would improve the gut function and reach the adequate energy supply.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutrition Disorder, Child

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
Randomized
Enrollment
256 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The patients' nutrition were supported according the the algorithm of the enteral nutrition.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The patients' nutrition were supported according the prescription of the physicians and dietician in our hospital.
Intervention Type
Other
Intervention Name(s)
intervention group
Intervention Description
When patients' hemodynamics was stable, start 1-2ml/kg/hr post-op 6-12 hours and increased 1-2ml/kg/hr each day if tolerating to reach the target energy supply When patients' hemodynamics wasn't stable, start post-op 6-12 hours 0.5-1ml/kg/hr and increased 0.5-1ml/kg/hr each day if tolerating to reach the target energy supply.
Primary Outcome Measure Information:
Title
Malnutrition recovery
Description
Malnutrition was assessed as recovering from malnutrition
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Feeding intolerance
Description
According to the criteria established by the American Academy of Pediatrics in 2003, the following symptoms are diagnosed as feeding intolerance: severe abdominal distension or discoloration; Signs of intestinal perforation; Obvious blood stool; Gastric retention ≥ 25% of the total amount after 2 to 3 feeding intervals; Bile reflux or vomiting; Severe apnea or bradycardia; Severe cardiopulmonary insufficiency; Apnea: Cessation of breathing for ≥20 seconds, or cessation of breathing accompanied by a decrease in SpO2.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: weight-for-age of z-score <-2; or length-for-age of z score <-2; or weight-for-length of z score <-2 Exclusion Criteria: Any patient with congenital genetic metabolic diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhuoming Xu, PhD
Organizational Affiliation
Shanghai Children's Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34765467
Citation
Chen X, Zhang M, Song Y, Luo Y, Wang L, Xu Z, Bao N. Early high-energy feeding in infants following cardiac surgery: a randomized controlled trial. Transl Pediatr. 2021 Oct;10(10):2439-2448. doi: 10.21037/tp-21-360.
Results Reference
derived

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Efficacy and Safety of the Algorithm for Enteral Nutrition Support

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