High‑calorie versus standard enteral feeding to support growth and brain development in infants after congenital heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Children's Hospital of Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Xu Yulu
• Email: xuyulu05@163.com
• Phone: 8602164931532

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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.