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Tests treatment safety and results for Congenital Heart Disease
Official title Effectiveness of High-Energy Density Enteral Nutrition for Enhancing Physical Growth and Cognitive Brain Development in Infants With Congenital Heart Disease
ClinicalTrials.gov ID: NCT07115108
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 6
You may be able to join 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
You likely can't join if
- Diagnosed with major non cardiac diseases leading to nutritional intake disorders, such as congenital gastrointestinal malformations, preoperative...
- Abnormal immune system function due to congenital or acquired factors, unable to effectively resist pathogens or eliminate abnormal cells, which can...
- 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
See the full eligibility 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 months to 6 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.