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IRCT20191224045880N1 IRCT 2020-02-18 Tehran University of Medical Sciences 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 2018-09-23 anticipated 40 Complete https://irct.ir/trial/44541 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Condition 1: congenital heart diseases. Condition 2: malnutrition. 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 formula to replace the regular formula. Infants who receive only breast milk will receive, at the discretion of the clinician, energy- and nutrient-dense formula. The dose of the administered energy- and nutrient-dense formula will initiate with 35 kcal/kg/day to reach 100 Kcal/kg/day.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information is available.
public Ehsan Aghaei Moghadam
Children's Medical Center, 62 Qarib St. , Keshavarz Blvd.
Tehran Iran (Islamic Republic of) 1419733151 +98 21 6694 9662 ehsanaghaei1358@gmail.com Tehran University of Medical Sciences scientific Ehsan Aghaei Moghadam
Children's Medical Center, 62 Qarib St. , Keshavarz Blvd., Tehran 14194, Iran
Tehran Iran (Islamic Republic of) 1419733151 +98 21 6694 9662 ehsanaghaei1358@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) children with moderate/high risk cardiac defects who are candidates for surgical repair being undernourished (Weight For Age z-score ≤ - 2) no limit 9 months Both 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 Q24.9 E64 Congenital malformation of heart, unspecified Sequelae of malnutrition and other nutritional deficiencies Treatment - Other 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 formula to replace the regular formula. Infants who receive only breast milk will receive, at the discretion of the clinician, energy- and nutrient-dense formula. The dose of the administered energy- and nutrient-dense formula will initiate with 35 kcal/kg/day to reach 100 Kcal/kg/day. 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. 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. Danone Nutricia Approved 2017-04-29 Ethics committee of Tehran University of Medical Sciences Children's Medical Center, 62 Qarib St. , Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)