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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20191224045880N1
Enrollment
40
Registered
2020-02-18
Start date
2018-09-23
Completion date
Unknown
Last updated
2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: congenital heart diseases. Condition 2: malnutrition. Congenital malformation of heart, unspecified Sequelae of malnutrition and other nutritional deficiencies

Interventions

Intervention group: In this study, infants on regular infant formula will be switched completely to energy- and nutrient-dense formula (100 kcal and 2.6 g protein per 100 ml
Infatrini®, Nutricia, Zoetermeer, the Netherlands). Infants who receive a combination of breast milk and regular infant formula will continue breast milk in addition to energy- and nutrient-dense form

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 9 Months

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactEhsan Aghaei Moghadam

Tehran University of Medical Sciences

ehsanaghaei1358@gmail.com+98 21 6694 9662

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026