Back to resultsNutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics
Primary Purpose
Congenital Heart Disease
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Nutritional perioperative prehabilitation program for two weeks
Nutritional perioperative prehabilitation program for one week
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Heart Disease
Eligibility Criteria
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
Sites / Locations
- 38 abbasia, next to nour mosque, Ain Shams University Hospital, Pediatrics department
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
two weeks prehabilitation group
one week prehabilitation group
Arm Description
Nutritional perioperative prehabilitation program for two weeks in malnourished congenital heart disease children
Nutritional perioperative prehabilitation program for one week in malnourished congenital heart disease children
Outcomes
Primary Outcome Measures
daily feeding characteristics
daily feeding characteristics
anthropometric and laboratory measure
anthropometric and laboratory measure
Secondary Outcome Measures
length of ICU stay
length of ICU stay
duration of mechanical ventilation and extubation timing
total days of mechanical ventilation
postoperative vital stability, surgical complication,nosocomial sepsis,inotropes withdrawal
same as above
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02475759
Brief Title
Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics
Official Title
Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics. A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
November 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics. A randomized controlled trial.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
two weeks prehabilitation group
Arm Type
Active Comparator
Arm Description
Nutritional perioperative prehabilitation program for two weeks in malnourished congenital heart disease children
Arm Title
one week prehabilitation group
Arm Type
Active Comparator
Arm Description
Nutritional perioperative prehabilitation program for one week in malnourished congenital heart disease children
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutritional perioperative prehabilitation program for two weeks
Other Intervention Name(s)
Nutritional perioperative prehabilitation program
Intervention Description
nutritional intervention received two weeks before surgical intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutritional perioperative prehabilitation program for one week
Other Intervention Name(s)
Nutritional perioperative prehabilitation program
Intervention Description
nutritional intervention received one weeks before surgical intervention
Primary Outcome Measure Information:
Title
daily feeding characteristics
Description
daily feeding characteristics
Time Frame
admission
Title
anthropometric and laboratory measure
Description
anthropometric and laboratory measure
Time Frame
admission
Secondary Outcome Measure Information:
Title
length of ICU stay
Description
length of ICU stay
Time Frame
3weeks
Title
duration of mechanical ventilation and extubation timing
Description
total days of mechanical ventilation
Time Frame
3 weeks
Title
postoperative vital stability, surgical complication,nosocomial sepsis,inotropes withdrawal
Description
same as above
Time Frame
admission
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
38 abbasia, next to nour mosque, Ain Shams University Hospital, Pediatrics department
City
Cairo
ZIP/Postal Code
11517
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics
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