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Evaluation of consumption of high caloric Infant Formula after surgery of Heart Defects

Evaluation of Energy-enriched Formula consumption on Congenital Heart Disease postoperative

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9tn862
Enrollment
Unknown
Registered
2018-04-11
Start date
2017-03-06
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Congenital heart disease Infant

Interventions

Experimental group: 60 children undergoing heart surgery will receive hypercaloric formula (1 kcal/ml), minimum of 120 kcal/kg/day, during the period of 30 days. Control group: 60 children undergoing
Dietary supplement
G07.203.100.712.249

Sponsors

Hospital da Criança Santo Antônio
Lead Sponsor
Danone LTDA
Collaborator

Eligibility

Age
No minimum to 23 Months

Inclusion criteria

Inclusion criteria: Two years old or less; both genders; undergoing heart surgery

Exclusion criteria

Exclusion criteria: Exclusive breastfeeding; Chylothorax

Design outcomes

Primary

MeasureTime frame
Mean Daily weight gain, evaluated through weighing scale the day before surgery and after the period of 30 days, it is expected a difference of 10g/day between groups

Secondary

MeasureTime frame
Reduction in length of stay in intensive care unit, evaluated through mean lengh of stay in each group, it is expected a reduction of 1 day in the intervention group; Reduction in length of hospital stay, evaluated through mean lengh of stay in each group, it is expected a reduction of 1 day in the intervention group; Reduction in infections after surgery, evaluated through infection rate in each group, it is expected a reduction in 5% in the intervention group.

Countries

Brazil

Contacts

Public ContactVanessa Scheeffer

Hospital da Criança Santo Antônio

vanessascheeffer@gmail.com55-51-981147524

Outcome results

None listed

Source: REBEC (via WHO ICTRP)