Congenital Heart Disease
Conditions
Keywords
high density formula, heart defects, infant
Brief summary
The purpose of this study is to explore the effects of high density formula in early postoperative infants with congenital heart disease and to assess its safety.
Detailed description
The number of infants born with CHD increases every year and most CHD infants are suffered with malnutrition.Recent studies have shown that increasing energy intake in CHD infants can improve their nutrition status.But there are no high qualified evidences supporting that high density formula can promote infants' nutrition status and ensure its safety. The hypothesis of the current study is that high density formula intake can increase infants'weight and it's safe. The current study adopts randomized,controlled intervention trial, gives high density formula(Infatrini,100kcal/100ml)to CHD infants in intervention group and normal density formula（Neocate,67kcal/100ml）in control group. Intervention begins when infants start enteral nutrition after operation and continues for 7days.
Interventions
DIETARY_SUPPLEMENTnormal density formula (Necocate)
In control group,there are 32 infants
DIETARY_SUPPLEMENThigh density formula(Infatrini)
In intervention group,there are 32 infants
Sponsors
Children's Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 12 Months
Healthy volunteers
No
Inclusion criteria
1. diagnosis of congenital heart disease from symptoms, signs, ultrasonic and imaging examination 2. aged from 1 day to 12 months 3. accept extracorporeal circulation open-heart surgery 4. family members voluntarily participate in this study
Exclusion criteria
1. patients have other diseases which cause nutrition disorders, such as gastrointestinal malformation, preoperative gastroesophageal reflux, genetic diseases related to the growth restriction 2. accept total parenteral nutrition 3. predicted the length of CCU stay is less than five days 4. patients have abdominal distention, diarrhea, vomiting
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| weight gain at the 7th day (g) | from the first day starting enteric feeding to the 7th days | the 7th day body weight minus baseline body weight |
| the number of participants with feeding intolerance | from the first day starting enteric feeding to the 7th day | Feeding intolerance means participants have gastric retention, vomiting, diarrhea ect. lead to enteric feeding was stopped. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of mechanical ventilation | participants will be followed for the duration of hospital stay, an expected average of 4 weeks | evaluate the long term effect of feeding high density formula |
| length of Cardiac Intensive Care Unit(CCU) stay | participants will be followed for the duration of hospital stay, an expected average of 4 weeks | evaluate the long term effect of feeding high density formula |
| the number of participants with poor wound healing | participants will be followed for the duration of hospital stay, an expected average of 4 weeks | evaluate the long term effect of feeding high density formula |
| the number of participants with necrotizing enterocolitis | participants will be followed for the duration of hospital stay, an expected average of 4 weeks | evaluate the long term effect of feeding high density formula |
Outcome results
None listed