NCT07115108

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Sep 2025

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Sep 2025Dec 2026

First Submitted

Initial submission to the registry

July 30, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

August 26, 2025

Status Verified

August 1, 2025

Enrollment Period

1.3 years

First QC Date

July 30, 2025

Last Update Submit

August 25, 2025

Conditions

Congenital Heart DiseaseEnteral NutritionPediatrics

Keywords

Congenital heart diseaseEnteral nutritionPediatrics

Outcome Measures

Primary Outcomes (1)

  • Weight-for-age z score (WAZ)

    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.

    6th month after discharge

Secondary Outcomes (11)

  • Weight-for-age z score (WAZ)

    Before discharge, 1st month, 3rd month after discharge

  • Cognitive development

    Before discharge, 1st month, 3rd month, 6th month after discharge

  • Incidence of subjects with Gastrointestinal mucosal barrier function injury

    Before discharge, 1 month, 3 months, 6 months after discharge

  • Albumin level

    Before discharge, 1 month, 3 months, 6 months after discharge

  • Blood lipid levels

    Before discharge, 1 month, 3 months, 6 months after discharge

  • +6 more secondary outcomes

Study Arms (2)

High energy density enteral nutrition

EXPERIMENTAL

High-energy-density enteral nutrition (100 cal/100 ml) will be administered to infants following surgery for congenital heart disease. The target feeding volume will be determined based on the infant's body weight (80-100 ml/kg), with the volume per feeding and frequency appropriately adjusted. Weight measurements and neurological assessments will be conducted at admission, prior to discharge, and at 1-, 3-, and 6-month intervals post-discharge. The safety of the intervention will be closely monitored throughout the study period.

Dietary Supplement: High energy density enteral nutrition

General energy density enteral nutrition

ACTIVE COMPARATOR

General energy density enteral nutrition (60-88cal/100 ml) will be administered to infants following surgery for congenital heart disease. The target feeding volume will be determined based on the infant's body weight (80-100 ml/kg), with the volume per feeding and frequency appropriately adjusted. Weight measurements and neurological assessments will be conducted at admission, prior to discharge, and at 1-, 3-, and 6-month intervals post-discharge. The safety of the intervention will be closely monitored throughout the study period.

Dietary Supplement: General energy density enteral nutrition

Interventions

High energy density enteral nutritionDIETARY_SUPPLEMENT

High-energy-density enteral nutrition (100 cal/100 ml) will be administered to infants following surgery for congenital heart disease. The target feeding volume will be determined based on the infant's body weight (80-100 ml/kg), with the volume per feeding and frequency appropriately adjusted.

Also known as: High energy density EN
High energy density enteral nutrition
General energy density enteral nutritionDIETARY_SUPPLEMENT

General energy density enteral nutrition (60-88 cal/100 ml) will be administered to infants following surgery for congenital heart disease. The target feeding volume will be determined based on the infant's body weight (80-100 ml/kg), with the volume per feeding and frequency appropriately adjusted.

Also known as: General energy density EN
General energy density enteral nutrition

Eligibility Criteria

Age0 Months - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang Uygur Autonomous Region, 830054, China

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Xu Yulu

CONTACT

8602164931532xuyulu05@163.com

Gu Ying

CONTACT

8602164931223guying0128@ailyun.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2025

First Posted

August 11, 2025

Study Start

September 15, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

August 26, 2025

Record last verified: 2025-08

Locations

CN(2)