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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
64
In control group,there are 32 infants
In intervention group,there are 32 infants
weight gain at the 7th day (g)
the 7th day body weight minus baseline body weight
Time frame: 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.
Time frame: from the first day starting enteric feeding to the 7th day
Duration of mechanical ventilation
evaluate the long term effect of feeding high density formula
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
length of Cardiac Intensive Care Unit(CCU) stay
evaluate the long term effect of feeding high density formula
Time frame: 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
Time frame: 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
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
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