Nutrition management for infants undergoing heart surgery
Official title: A Multi-center Longitudinal Cohort Study on Peri-operative Nutrition in Infants With Congenital Heart Disease
Run by Guangzhou Medical University · NCT03626480 · Data updated 2026-11-12
This study is testing how managing nutrition before and after heart surgery can help infants with congenital heart disease recover better and improve their long-term health.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Day to 12 Months |
| Sex | All |
| Enrollment | 20000 (estimated) |
| Sponsor | Guangzhou Medical University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | July 9, 2018 |
| Main results expected | September 1, 2028 |
| Study ends | September 1, 2028 |
| Registry record updated | February 11, 2020 |
| Trial ID | NCT03626480 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are infants under one year old diagnosed with congenital heart disease who are scheduled for surgical intervention.
✕Probably not a fit
Patients with chromosomal diseases, genetic metabolic disorders, or those with conditions affecting oral feeding may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multi-center cohort study aims to monitor the peri-operative nutrition of infants diagnosed with congenital heart disease who are scheduled for surgery. Data will be collected at various intervals, including pre-surgery and at 1, 3, 6, and 12 months post-surgery, focusing on nutritional status, biochemical indices, and quality of life. The study seeks to understand the impact of nutritional management on recovery and long-term health outcomes in these children, addressing the challenges posed by surgery and potential malnutrition.
Why it matters
Potential benefit: If successful, this study could improve nutritional outcomes and overall recovery for infants with congenital heart disease undergoing surgery.
How similar studies have gone: While there is limited data on similar studies, the focus on peri-operative nutrition in this specific population is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
-
The Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Principal investigator: Yanqin Cui, MPh — Guangzhou Women and Children's Medical Center
- Study coordinator: Lijuan Li, MD
- Email: 397413149@qq.com
- Phone: 8620-38076234
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.