Efficacy and Safety of the Algorithm for Enteral Nutrition Support
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.
1 other identifier
interventional
256
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
April 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedFirst Posted
Study publicly available on registry
October 30, 2020
CompletedOctober 30, 2020
October 1, 2020
1.6 years
April 4, 2017
October 25, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Malnutrition recovery
Malnutrition was assessed as recovering from malnutrition
1 year
Secondary Outcomes (1)
Feeding intolerance
1 year
Study Arms (2)
Intervention group
EXPERIMENTALThe patients' nutrition were supported according the the algorithm of the enteral nutrition.
Control group
NO INTERVENTIONThe patients' nutrition were supported according the prescription of the physicians and dietician in our hospital.
Interventions
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.
Eligibility Criteria
You may qualify if:
- weight-for-age of z-score \<-2; or length-for-age of z score \<-2; or weight-for-length of z score \<-2
You may not qualify if:
- Any patient with congenital genetic metabolic diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200127, China
Related Publications (1)
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.
PMID: 34765467DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Zhuoming Xu, PhD
Shanghai Children's Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of CICU
Study Record Dates
First Submitted
April 4, 2017
First Posted
October 30, 2020
Study Start
January 1, 2017
Primary Completion
July 31, 2018
Study Completion
December 31, 2019
Last Updated
October 30, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share