Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics

NCT ID: NCT02475759

Last Updated: 2022-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2019-11-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Congenital Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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two weeks prehabilitation group

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

Group Type ACTIVE_COMPARATOR

Nutritional perioperative prehabilitation program for two weeks

Intervention Type DIETARY_SUPPLEMENT

nutritional intervention received two weeks before surgical intervention

one week prehabilitation group

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

Group Type ACTIVE_COMPARATOR

Nutritional perioperative prehabilitation program for one week

Intervention Type DIETARY_SUPPLEMENT

nutritional intervention received one weeks before surgical intervention

Interventions

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Nutritional perioperative prehabilitation program for two weeks

nutritional intervention received two weeks before surgical intervention

Intervention Type DIETARY_SUPPLEMENT

Nutritional perioperative prehabilitation program for one week

nutritional intervention received one weeks before surgical intervention

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Nutritional perioperative prehabilitation program Nutritional perioperative prehabilitation program

Eligibility Criteria

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Inclusion 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.

Exclusion Criteria

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Rania Ali El-Farrash

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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ASU 015

Identifier Type: -

Identifier Source: org_study_id

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