Effect of a High Density Formula on Growth and Safety in Congenital Heart Disease Infants

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of a High Density Formula on Growth and Safety in Early Postoperative Infants With Congenital Heart Disease Duration of Cardiac Intensive Care Unit（CCU）Stay: a Randomized Clinical Trial

Conditions
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Congenital Heart Disease

Intervention / Treatment
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* Dietary Supplement: normal density formula (Necocate)
* Dietary Supplement: high density formula(Infatrini)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of congenital heart disease from symptoms, signs, ultrasonic and imaging examination aged from 1 day to 12 months accept extracorporeal circulation open-heart surgery family members voluntarily participate in this study Exclusion Criteria: patients have other diseases which cause nutrition disorders, such as gastrointestinal malformation, preoperative gastroesophageal reflux, genetic diseases related to the growth restriction accept total parenteral nutrition predicted the length of CCU stay is less than five days patients have abdominal distention, diarrhea, vomiting

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: normal density formula (Neocate)<br>In control group,infants intake normal density formula (Neocate,67kcal/100ml) when starting enteral nutrition after operation and continue for 7days | Dietary Supplement: normal density formula (Necocate)<br>* In control group,there are 32 infants<br>|
| Experimental: high density formula (Infatrini)<br>In the intervention group,infants intake high density formula (Infatrini, 100kcal/100ml) when starting enteral nutrition after operation and continue for 7days | Dietary Supplement: high density formula(Infatrini)<br>* In intervention group,there are 32 infants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high density formula, heart defects, infant