Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics

February 15, 2022 updated by: Rania Ali El-Farrash, Ain Shams University

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

Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics. A randomized controlled trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11517
        • 38 abbasia, next to nour mosque, Ain Shams University Hospital, Pediatrics department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: two weeks prehabilitation group
Nutritional perioperative prehabilitation program for two weeks in malnourished congenital heart disease children
Dietary supplement: Nutritional perioperative prehabilitation program for two weeks
nutritional intervention received two weeks before surgical intervention
Other Names:
  • Nutritional perioperative prehabilitation program
Active Comparator: one week prehabilitation group
Nutritional perioperative prehabilitation program for one week in malnourished congenital heart disease children
Dietary supplement: Nutritional perioperative prehabilitation program for one week
nutritional intervention received one weeks before surgical intervention
Other Names:
  • Nutritional perioperative prehabilitation program

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

March 10, 2015

First Submitted That Met QC Criteria

June 16, 2015

First Posted (Estimate)

June 19, 2015

Study Record Updates

Last Update Posted (Actual)

March 3, 2022

Last Update Submitted That Met QC Criteria

February 15, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASU 015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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