Nutrition management for infants undergoing heart surgery
A Multi-center Longitudinal Cohort Study on Peri-operative Nutrition in Infants With Congenital Heart Disease
Guangzhou Medical University · NCT03626480
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 |
|---|---|
| Enrollment | 20000 (estimated) |
| Ages | 1 Day to 12 Months |
| Sex | All |
| Sponsor | Guangzhou Medical University (other) |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT03626480 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are infants under one year old diagnosed with congenital heart disease who are scheduled for surgical intervention.
Not a fit: Patients with chromosomal diseases, genetic metabolic disorders, or those with conditions affecting oral feeding may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hangzhou, Zhejiang
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Congenital Heart Disease, Surgery, Nutritional outcome, Infants