Efficacy and Safety of the Algorithm for Enteral Nutrition Support

Sponsor

Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT04609358

Collaborator

(none)

256

Enrollment

Location

Arms

35.9

Actual Duration (Months)

7.1

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Nutrition Disorder, Child	Other: intervention group	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

256 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

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.

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Jul 31, 2018

Actual Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group The patients' nutrition were supported according the the algorithm of the enteral nutrition.	Other: intervention group 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.
No Intervention: Control group The patients' nutrition were supported according the prescription of the physicians and dietician in our hospital.

Arm

Intervention/Treatment

Experimental: Intervention group

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

Other: intervention group

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.

No Intervention: Control group

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

Outcome Measures

Primary Outcome Measures

Malnutrition recovery [1 year]
Malnutrition was assessed as recovering from malnutrition

Secondary Outcome Measures

Feeding intolerance [1 year]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 6 Months

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University	Shanghai	Shanghai	China	200127

Sponsors and Collaborators

Shanghai Jiao Tong University School of Medicine

Investigators

Study Director: Zhuoming Xu, PhD, Shanghai Children's Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xu Zhuoming, Director of CICU, Shanghai Jiao Tong University School of Medicine

ClinicalTrials.gov Identifier:

NCT04609358

Other Study ID Numbers:

SCMCIRB-K2015003

First Posted:

Oct 30, 2020

Last Update Posted:

Oct 30, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Nutrition Disorders

Child Nutrition Disorders

Study Results

No Results Posted as of Oct 30, 2020