Clinical Trials in China / NCT03626480
Recruiting
Observational
Peri-operative Nutrition in Infants With Congenital Heart Disease
NCT03626480 · tracked via the Priya Life Science China tracker
Condition(s) studied
Congenital Heart Disease
Investigational drug(s) / intervention(s)
No treatment
No treatment: No treatment
Study 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.
Eligibility
Inclusion Criteria:
* All children in the multi-center who met the following criteria:
1. under 1 years old (including 1 years old);
2. diagnosed as congenital heart disease and planed to surgery;
3. parents have basic literacy skills, communication and accessibility
4. parents are informed consent and volunteered to participate with the approval of the hospital ethics committee,
Exclusion Criteria:
* (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)
Primary outcome measure(s)
- Change in infants' height and weight — baseline, 1, 3, 6 and 12 months
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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| The Children's Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03626480 on ClinicalTrials.gov ↗ ← All trials in China