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NCT Number: NCT02475759

Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics

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

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

38 abbasia, next to nour mosque, Ain Shams University Hospital, Pediatrics department

Cairo, 11517, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutritional perioperative prehabilitation program for two weeks

Dietary Supplement

nutritional intervention received two weeks before surgical intervention

Other names: Nutritional perioperative prehabilitation program

Nutritional perioperative prehabilitation program for one week

Dietary Supplement

nutritional intervention received one weeks before surgical intervention

Other names: Nutritional perioperative prehabilitation program

Primary outcomes

  1. daily feeding characteristics

    Time frame: admission

    daily feeding characteristics

  2. anthropometric and laboratory measure

    Time frame: admission

    anthropometric and laboratory measure

Secondary outcomes

  1. length of ICU stay

    Time frame: 3weeks

    length of ICU stay

  2. duration of mechanical ventilation and extubation timing

    Time frame: 3 weeks

    total days of mechanical ventilation

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

    Time frame: admission

    same as above

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 19, 2015
Registry last updated
Mar 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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