Efficacy and Safety of the Algorithm for Enteral Nutrition Support

NCT ID: NCT04609358

Last Updated: 2020-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Nutrition Disorder, Child

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

intervention group

Intervention Type OTHER

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.

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Xu Zhuoming

Director of CICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhuoming Xu, PhD

Role: STUDY_DIRECTOR

Shanghai Children's Medical Center

Locations

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

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 34765467 (View on PubMed)

Other Identifiers

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SCMCIRB-K2015003

Identifier Type: -

Identifier Source: org_study_id