Effectiveness of High-Energy Density Enteral Nutrition for Enhancing Physical Growth and Cognitive Brain Development in Infants With Congenital Heart Disease

Not Applicable

Not yet recruiting

• Conditions: Congenital Heart Disease; Enteral Nutrition; Pediatrics

• Registration Number: NCT07115108
• Lead Sponsor: Children's Hospital of Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-30
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-04
• Last Update Submitted: 2025-08-04
• Study First Posted: 2025-08-11
• Last Update Posted: 2025-08-11
• Study Start: 2025-08-15
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Diagnosed with congenital heart disease through symptoms, physical signs, imaging, and ultrasound examinations.
• Age 0-6 months
• Malnutrition, with weight-for-age (WAZ) < -2
• Artificial 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).
• Children receiving total parenteral nutrition, mixed feeding, or exclusive breastfeeding after surgery.
• 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
• Over nutrition, with weight-for-age (WAZ) >+2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Weight-for-age z score (WAZ)	6th month after discharge	WAZ is calculated according to the Chinese child growth curve and cut-offs .It is a statistical index used to assess the nutritional status of children. The physical examination will be conducted by a nurse, and the data will be recorded to one decimal place.

Secondary Outcome Measures

Name	Time	Method
Weight-for-age z score (WAZ)	Before discharge, 1st month, 3rd month after discharge	WAZ is calculated according to the Chinese child growth curve and cut-offs .It is a statistical index used to assess the nutritional status of children. The physical examination will be conducted by a nurse, and the data will be recorded to one decimal place.
Albumin level	Before discharge, 1 month, 3 months, 6 months after discharge	Albumin is a rich protein in the blood, which mainly reflects the nutritional status.The reference range for albumin is 39-54g/L.If it is not within this range, it will be judged as abnormal.
Energy intake (cal/d)	During hospitalization, before discharge, 1 month, 3 months, 6 months after discharge	Calculate the caloric intake for enteral feeding according to the Schofeld formula recommended by the European Society for Pediatric and Neonatal Intensive Care (ESPNIC)
Incidence of malabsorption	During hospitalization, before discharge, 1 month, 3 months, 6 months after discharge	Incidence of malabsorption (as defined by any of the following criteria): abnormal fecal lactose content; abnormal fecal fat content.The diagnosis will be confirmed by fecal examination.
Cognitive development	Before discharge, 1st month, 3rd month, 6th month after discharge	The Griffiths mental development scales (GMDs) will be used to repeatedly measure the indicators .The Griffiths scales typically yield a Developmental Quotient (DQ) with an average range of 85-115. The higher the scores, the more advanced development relative to age norms in assessed domains (e.g., motor, language, or cognition).
Incidence of subjects with Gastrointestinal mucosal barrier function injury	Before discharge, 1 month, 3 months, 6 months after discharge	Primarily defined by elevation in fecal calprotectin and Inflammatory cytokines level.The reference range for calprotectin is 0-5 μg/g，inflammatory cytokines is ≤20pg/ml.Exceeding this range will be considered as abnormal gastrointestinal mucosal barrier function.
Blood lipid levels	Before discharge, 1 month, 3 months, 6 months after discharge	Blood lipid test is to measure the content of lipids in blood.Blood lipids include total cholesterol(0-5.18mmol/L) and triglycerides(0-1.7mmol/L).If it exceeds the range, it will be considered as abnormal.
Incidence of feeding intolerance	During hospitalization, before discharge, 1 month, 3 months, 6 months after discharge	Any of the following condition: 1. Frequent vomiting (≥ 3 times/d); 2.Abdominal distension; 3. Milk volume did not increase or decreased\>3 d; 4. Gastric retention (retention\>1/3 of the previous feeding); 5. Unplanned discontinuation of feeding ≥ 2 times; 6. Diarrhea (stool frequency\>6 times/d)
Enteral Nutrition intake (ml/d)	During hospitalization, before discharge, 1 month, 3 months, 6 months after discharge	Based on the child's weight and the fluid balance in the previous 24 hours, the total fluid intake for the day is calculated. After subtracting the amount of intravenous drug solution, the amount of enteral nutrition formula is obtained. According to the child's gastrointestinal function, the principle of gradual progress is adopted to rationally allocate the single feeding volume and feeding frequency.
Incidence of necrotizing enterocolitis（NEC）	Before discharge, 1 month, 3 months, 6 months after discharge	NEC diagnosed in stage II and III will be recorded.
Other surgical indications	At the day of discharge, an average of 3 week after surgery	Mechanical ventilation time (days), postoperative CCU hospitalization duration (days), total hospitalization duration (days), hospitalization costs (Yuan), and the incidence of poor wound healing will be recorded.

Trial Locations

Locations (2)

Children's Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China

The First Affiliated Hospital of Xinjiang Medical University; 🇨🇳 Ürümqi, Xinjiang Uygur Autonomous Region, China