Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics

NCT02475759 | Completed DMC

• 1 other identifier: ASU 015
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (2)

• daily feeding characteristics

  daily feeding characteristics

  admission

• anthropometric and laboratory measure

  anthropometric and laboratory measure

  admission

Secondary Outcomes (3)

• length of ICU stay

  3weeks

• duration of mechanical ventilation and extubation timing

  3 weeks

• postoperative vital stability, surgical complication,nosocomial sepsis,inotropes withdrawal

  admission

Study Arms (2)

two weeks prehabilitation group

ACTIVE COMPARATOR

Nutritional perioperative prehabilitation program for two weeks in malnourished congenital heart disease children

Dietary Supplement: Nutritional perioperative prehabilitation program for two weeks

one week prehabilitation group

ACTIVE COMPARATOR

Nutritional perioperative prehabilitation program for one week in malnourished congenital heart disease children

Dietary Supplement: Nutritional perioperative prehabilitation program for one week

Interventions

Nutritional perioperative prehabilitation program for two weeks DIETARY_SUPPLEMENT

nutritional intervention received two weeks before surgical intervention

Also known as: Nutritional perioperative prehabilitation program

two weeks prehabilitation group

Nutritional perioperative prehabilitation program for one week DIETARY_SUPPLEMENT

nutritional intervention received one weeks before surgical intervention

Also known as: Nutritional perioperative prehabilitation program

one week prehabilitation group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

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

Cairo, 11517, Egypt

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 10, 2015
• First Posted: June 19, 2015
• Study Start: November 1, 2017
• Primary Completion: October 1, 2019
• Study Completion: November 1, 2019
• Last Updated: March 3, 2022

Record last verified: 2022-02

Locations

EG (1)