Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics

Study Overview
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Brief Summary
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Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics. A randomized controlled trial.

Detailed Description
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Nutritional Prehabilitation Program and Cardiac Surgery in Pediatrics. A randomized controlled trial to compare the outcome of malnourished congenital heart surgery patients who randomly received nutritional rehabilitation program 2 weeks and 1 week before surgical intervention.

Official Title
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Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics. A Randomized Controlled Trial

Conditions
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Congenital Heart Disease

Intervention / Treatment
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* Dietary Supplement: Nutritional perioperative prehabilitation program for two weeks
* Dietary Supplement: Nutritional perioperative prehabilitation program for one week


Participation Criteria
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Eligibility Criteria
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The study included all infants with CHD, admitted to the cardiothoracic unit for either palliative or corrective surgery, and suffering from nutritional deficiencies with moderate or severe malnutrition . Infants received long-term nutritional prehabiliatation. Those with congenital or acquired anomaly of the gastrointestinal tract; multiple congenital anomalies; chromosomal, metabolic,or endocrine diseases; any systemic illness; or fever or infection within 1 wk before the study entry were excluded
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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: two weeks prehabilitation group<br>Nutritional perioperative prehabilitation program for two weeks in malnourished congenital heart disease children | Dietary Supplement: Nutritional perioperative prehabilitation program for two weeks<br>* nutritional intervention received two weeks before surgical intervention<br>* Other names: Nutritional perioperative prehabilitation program;|
| Active Comparator: one week prehabilitation group<br>Nutritional perioperative prehabilitation program for one week in malnourished congenital heart disease children | Dietary Supplement: Nutritional perioperative prehabilitation program for one week<br>* nutritional intervention received one weeks before surgical intervention<br>* Other names: Nutritional perioperative prehabilitation program;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| daily feeding characteristics | daily feeding characteristics | admission | 
| anthropometric and laboratory measure | anthropometric and laboratory measure | admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of ICU stay | length of ICU stay | 3weeks | 
| duration of mechanical ventilation and extubation timing | total days of mechanical ventilation | 3 weeks | 
| postoperative vital stability, surgical complication,nosocomial sepsis,inotropes withdrawal | same as above | admission |