High‑calorie versus standard enteral feeding to support growth and brain development in infants after congenital heart surgery
Effectiveness of High-Energy Density Enteral Nutrition for Enhancing Physical Growth and Cognitive Brain Development in Infants With Congenital Heart Disease: A Randomized Controlled Study
This trial tests whether higher‑calorie tube or bottle feeding helps infants with congenital heart disease grow better and support early brain development after open‑heart surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 0 Months to 6 Months |
| Sex | All |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07115108 on ClinicalTrials.gov |
What this trial studies
Infants aged 0–6 months who have nutritional risk and undergo open heart surgery will receive either a high‑energy density enteral nutrition regimen or a standard‑energy regimen during postoperative recovery. The study compares physical growth measures (such as weight and length) and cognitive brain development outcomes between the two feeding approaches and monitors safety events. Guardians must consent before enrollment and feeding will be provided while children are on artificial or mixed feeding. Investigators will track growth over the postoperative period and use standardized developmental screening tools to capture early neurodevelopmental differences.
Who should consider this trial
Good fit: Infants 0–6 months with diagnosed congenital heart disease, identified nutritional risk by STRONGkids, receiving artificial or mixed feeding, and scheduled for open heart surgery whose guardians provide informed consent.
Not a fit: Infants with major noncardiac conditions that impair feeding or growth (for example congenital gastrointestinal malformations, significant genetic syndromes like trisomy 21 or 18, or severe immune dysfunction) are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the higher‑calorie enteral feeding could improve postoperative weight gain and support early cognitive development, reducing malnutrition and its downstream risks.
How similar studies have performed: Previous nutrition studies in preterm and medically vulnerable infants have shown that higher‑energy formulas can improve weight gain, but evidence specifically showing cognitive benefit after congenital heart surgery is limited and this application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with congenital heart disease through symptoms, physical signs, imaging, and ultrasound examinations. * Age 0-6 months * Children with nutritional risks (defined by STRONGkids: Nutritional risk screening tool for children ) * Artificial or mixed feeding * Open heart surgery under cardiopulmonary bypass * The guardians of the children voluntarily participate in this study and sign a written informed consent form before the surgery. Exclusion Criteria: * Diagnosed with major non cardiac diseases leading to nutritional intake disorders, such as congenital gastrointestinal malformations, preoperative diagnosis of gastroesophageal reflux, genetic diseases related to growth restriction, and various syndromes with chromosomal abnormalities (trisomy 21 syndrome, trisomy 18 syndrome) * Abnormal immune system function due to congenital or acquired factors, unable to effectively resist pathogens or eliminate abnormal cells, which can be divided into primary and secondary immunodeficiencies. * Any pre - operative history of neurological diseases (e.g., encephalitis, epilepsy). * Secondary or primary gastrointestinal infection symptoms such as abdominal distension and diarrhea after surgery. * Estimated stay time in the postoperative intensive care unit ≤ 2 days
Where this trial is running
Shanghai, Shanghai Municipality
- Children's Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Xu Yulu
- Email: xuyulu05@163.com
- Phone: 8602164931532
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.