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Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT02475759
Collaborator
(none)
52
Enrollment
1
Location
2
Arms
24
Actual Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Nutritional perioperative prehabilitation program for two weeks
  • Dietary Supplement: Nutritional perioperative prehabilitation program for one week
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics. A Randomized Controlled Trial
Actual Study Start Date :
Nov 1, 2017
Actual Primary Completion Date :
Oct 1, 2019
Actual Study Completion Date :
Nov 1, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. daily feeding characteristics [admission]

      daily feeding characteristics

    2. anthropometric and laboratory measure [admission]

      anthropometric and laboratory measure

    Secondary Outcome Measures

    1. length of ICU stay [3weeks]

      length of ICU stay

    2. duration of mechanical ventilation and extubation timing [3 weeks]

      total days of mechanical ventilation

    3. postoperative vital stability, surgical complication,nosocomial sepsis,inotropes withdrawal [admission]

      same as above

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 38 abbasia, next to nour mosque, Ain Shams University Hospital, Pediatrics department Cairo Egypt 11517

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rania Ali El-Farrash, principal investigator, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT02475759
    Other Study ID Numbers:
    • ASU 015
    First Posted:
    Jun 19, 2015
    Last Update Posted:
    Mar 3, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Heart Diseases
    Heart Defects, Congenital

    Study Results

    No Results Posted as of Mar 3, 2022