Nutrition Disorder, Child
Conditions
Brief summary
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
Detailed description
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.
Interventions
OTHERintervention group
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.
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
1 Days to 6 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Malnutrition recovery | 1 year | Malnutrition was assessed as recovering from malnutrition |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feeding intolerance | 1 year | 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. |
Countries
China
Outcome results
None listed