NCT07115108 Effectiveness of High-Energy Density Enteral Nutrition for Enhancing Physical Growth and Cognitive Brain Development in Infants With Congenital Heart Disease
| NCT ID | NCT07115108 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital of Fudan University |
| Condition | Congenital Heart Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2025-10-13 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2025-10-13 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to compare the effect of high and ordinary energy density enteral nutrition for improving physical growth and brain cognitive development in infants with congenital heart disease after operation, as well as evaluate the safety of interventions.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07115108 clinical trial?
This trial is open to participants of all sexes, aged 0 Months or older, up to 6 Months, studying Congenital Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07115108 currently recruiting?
Yes, NCT07115108 is actively recruiting participants. Contact the research team at xuyulu05@163.com for enrollment information.
Where is the NCT07115108 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07115108 clinical trial?
NCT07115108 is sponsored by Children's Hospital of Fudan University. The trial plans to enroll 160 participants.