Clinical trial Recruiting at 1 site Observational Ages 1 Day to 12 Months

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 typeObservational
Ages1 Day to 12 Months
SexAll
Enrollment20000 (estimated)
SponsorGuangzhou Medical University
Academic / other
Locations1 site (Hangzhou, Zhejiang)
StatusRecruiting
StartedJuly 9, 2018
Main results expectedSeptember 1, 2028
Study endsSeptember 1, 2028
Registry record updatedFebruary 11, 2020
Trial IDNCT03626480 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.