utritional support with energy and nutrient-dense formula for children with congenital heart defects: A clinical trial

Phase 2

• Conditions: Condition 1: congenital heart diseases. Condition 2: malnutrition.; Congenital malformation of heart, unspecified; Sequelae of malnutrition and other nutritional deficiencies; Q24.9

• Registration Number: IRCT20191224045880N1
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 February 2020

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

children with moderate/high risk cardiac defects who are candidates for surgical repair
being undernourished (Weight For Age z-score = - 2)

Exclusion Criteria

Infants known to have non-cardiac medical problems that could independently affect nutrient intake, such as gastrointestinal malformations, renal failure, liver disease, neurological sequelae
genetic conditions associated with growth failure
Infants with low risk cardiac defects
presence of cow’s milk allergy and galactosaemia
history of operation within 4 weeks from the time of screening
receiving parenteral nutrition

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight for age Z score. Timepoint: 3,6,9,12 weeks after the administration of the high-energy- high protein formula. Method of measurement: scale.

Secondary Outcome Measures

Name	Time	Method
Weight for length Z score. Timepoint: 3,6,9,12 weeks after the administration of the high energy-high protein formula. Method of measurement: scale and meter.;Length for age Z score. Timepoint: 3,6,9,12 weeks after the administration of the high energy-high protein formula. Method of measurement: meter.;Head circumference. Timepoint: 3,12 weeks after the administration of the high energy-high protein formula. Method of measurement: meter.;Mid-upper arm circumference. Timepoint: 3,12 weeks after the administration of the high energy-high protein formula. Method of measurement: meter.