Efficacy and Safety of the Algorithm for Enteral Nutrition Support

Shanghai Jiao Tong University School of Medicine

Status: Completed

Conditions: Nutrition Disorder, Child

Treatments: Other: intervention group

Study type: Interventional

Funder types: Other

Identifiers

NCT04609358

SCMCIRB-K2015003

Details and patient eligibility

About

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

Full 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.

Enrollment: 256 patients

Sex: All

Ages: 1 day to 6 months old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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256 participants in 2 patient groups

Intervention group

Experimental group

Description:

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

Treatment:

Other: intervention group

Control group

No Intervention group

Description:

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