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The purpose of this trial is to evaluate the efficacy and safety of the implementation of an algorithm for enteral nutrition support compared with usual standard practice in children with malnutrition status with congenital heart disease
In many developing countries, pediatric cardiac programs are not fully established, and nutrition support algorithm is lack. Therefore, this study aimed to evaluate the the efficacy and safety of the implementation of an algorithm for enteral nutrition support compared with usual standard practice in children with malnutrition status with congenital heart disease. The usual standard practice for feeding often interrupted by retention in the gut and then choose the parenteral nutrition support especially in the patients with unstable hemodynamic status. Actually tiny and continuous feeding would improve the gut function and reach the adequate energy supply.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | The patients' nutrition were supported according the the algorithm of the enteral nutrition. |
|
| Control group | No Intervention | The patients' nutrition were supported according the prescription of the physicians and dietician in our hospital. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intervention group | Other | When patients' hemodynamics was stable, start 1-2ml/kg/hr post-op 6-12 hours and increased 1-2ml/kg/hr each day if tolerating to reach the target energy supply When patients' hemodynamics wasn't stable, start post-op 6-12 hours 0.5-1ml/kg/hr and increased 0.5-1ml/kg/hr each day if tolerating to reach the target energy supply. |
| Measure | Description | Time Frame |
|---|---|---|
| Malnutrition recovery | Malnutrition was assessed as recovering from malnutrition | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Feeding intolerance | According to the criteria established by the American Academy of Pediatrics in 2003, the following symptoms are diagnosed as feeding intolerance: severe abdominal distension or discoloration; Signs of intestinal perforation; Obvious blood stool; Gastric retention ≥ 25% of the total amount after 2 to 3 feeding intervals; Bile reflux or vomiting; Severe apnea or bradycardia; Severe cardiopulmonary insufficiency; Apnea: Cessation of breathing for ≥20 seconds, or cessation of breathing accompanied by a decrease in SpO2. |
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Inclusion Criteria:
weight-for-age of z-score <-2; or length-for-age of z score <-2; or weight-for-length of z score <-2
Exclusion Criteria:
Any patient with congenital genetic metabolic diseases
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| Name | Affiliation | Role |
|---|---|---|
| Zhuoming Xu, PhD | Shanghai Children's Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University | Shanghai | Shanghai Municipality | 200127 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34765467 | Derived | Chen X, Zhang M, Song Y, Luo Y, Wang L, Xu Z, Bao N. Early high-energy feeding in infants following cardiac surgery: a randomized controlled trial. Transl Pediatr. 2021 Oct;10(10):2439-2448. doi: 10.21037/tp-21-360. |
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| ID | Term |
|---|---|
| D015362 | Child Nutrition Disorders |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 1 year |