Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| normal density formula (Neocate) | Active Comparator | In control group,infants intake normal density formula (Neocate,67kcal/100ml) when starting enteral nutrition after operation and continue for 7days |
|
| high density formula (Infatrini) | Experimental | In the intervention group,infants intake high density formula (Infatrini, 100kcal/100ml) when starting enteral nutrition after operation and continue for 7days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| normal density formula (Necocate) | Dietary Supplement | In control group,there are 32 infants |
|
| Measure | Description | Time Frame |
|---|---|---|
| weight gain at the 7th day (g) | the 7th day body weight minus baseline body weight | from the first day starting enteric feeding to the 7th days |
| the number of participants with feeding intolerance | Feeding intolerance means participants have gastric retention, vomiting, diarrhea ect. lead to enteric feeding was stopped. | from the first day starting enteric feeding to the 7th day |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of mechanical ventilation | evaluate the long term effect of feeding high density formula | participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| length of Cardiac Intensive Care Unit(CCU) stay |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gu Ying, docter | Children Hospital of Fudan University | Study Chair |
Not provided
Not provided
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| high density formula(Infatrini) | Dietary Supplement | In intervention group,there are 32 infants |
|
evaluate the long term effect of feeding high density formula
| participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| the number of participants with poor wound healing | evaluate the long term effect of feeding high density formula | participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| the number of participants with necrotizing enterocolitis | evaluate the long term effect of feeding high density formula | participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |