Peri-operative Nutrition in Infants With Congenital Heart Disease
A Multi-center Longitudinal Cohort Study on Peri-operative Nutrition in Infants With Congenital Heart Disease
1 other identifier
observational
20,000
1 country
1
Brief Summary
The purpose of our multi-center cohort study is to build a large platform to follow up the peri-operative nutrition of children with congenital heart disease. And data will be collected pre and 1, 3, 6, 12 months post surgery including physical, laboratory, imaging examination and questionnaire. The primary outcome is nutrition status (measured as WAZ, WHZ and HAZ) and secondary outcomes were the biochemical index and quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2018
Longer than P75 for all trials
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
July 9, 2018
CompletedFirst Submitted
Initial submission to the registry
August 1, 2018
CompletedFirst Posted
Study publicly available on registry
August 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2028
February 11, 2020
February 1, 2020
10.2 years
August 1, 2018
February 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in infants' height and weight
Measured as : WAZ (weight-for-age z-score), WHZ (weight-for-height z-score), HAZ (height-for-age z-score). Children's height and weight will be measured pre and 1, 3, 6, 12 months post surgery.
baseline, 1, 3, 6 and 12 months
Secondary Outcomes (3)
Change of Biomedical index level
baseline, 1, 3, 6 and 12 months
Change in ROSS score
baseline, 1, 3, 6 and 12 months
Change in Alberta Infant Motor Scale (AIMS)
baseline, 1, 3, 6 and 12 months
Interventions
No treatment
Eligibility Criteria
Infants under 1 years old in the multi-center with congenital heart disease and planed to surgery
You may qualify if:
- All children in the multi-center who met the following criteria:
- under 1 years old (including 1 years old);
- diagnosed as congenital heart disease and planed to surgery;
- parents have basic literacy skills, communication and accessibility
- parents are informed consent and volunteered to participate with the approval of the hospital ethics committee,
You may not qualify if:
- (1) suspected as chromosomal disease; (2) diagnosis of genetic metabolic diseases; (3) anyway affecting oral feeding (eg. Cleft palate) (4) previous gastrointestinal surgery (eg. Postoperative gastrointestinal fistula)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yanqin Cui, MPh
Guangzhou Women and Children's Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of CICU
Study Record Dates
First Submitted
August 1, 2018
First Posted
August 13, 2018
Study Start
July 9, 2018
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
September 1, 2028
Last Updated
February 11, 2020
Record last verified: 2020-02