Nutrition In Preoperative Pediatric Congenital Heart Disease

Summary

Introduction: The use of a nutritional protocols provides the standardization of assessment procedures and the optimization of nutritional status recovery of pre-surgical infants with Congenital Heart Disease (CHD). However, to our knowledge there are no validated instrument for presurgical nutritional support for infants with congenital heart disease (CHD) in Brazil.

Objective: Assess the clinical effectiveness of the translated and cross-culturally adapted protocol, Nutritional Pathway for Infants with Congenital Heart Disease before Surgery (Marino et al., 2018), on the weight change of infants with congenital heart disease in two specialized cardiology hospitals in Southern Brazil in partnership with the UK research group that authored the original of protocol.

Methods: A randomized, pragmatic clinical trial will be carried out. The sample will consist of children with CHD, between 0-12 months of age, awaiting cardiovascular corrective surgery from the Pediatric Outpatient Clinic in the Institute of Cardiology (IC) and Children's Hospital Santo Antonio of Santa Casa de Misericordia. The previously translated pre-surgical nutritional intervention protocol for infants with congenital heart disease will be compared with current routine nutritional guidelines used in the follow-up services of children with congenital heart disease in these institutions within the national public healthcare, SUS.

Intended results: It is expected that the culturally-adapted pre-surgical nutritional support protocol for children with congenital heart disease will be effective in pre-surgical infant weight gain, which will likely improve surgical prognosis and clinical outcomes. And we hope that this protocol will promote the standardization of care, and will provide an empirically-based nutritional intervention that may improve the effectiveness of nutritional recovery in the CHD infants. Furthermore, the results may be used in the formulation of Brazilian guidelines for comprehensive care of children with congenital heart disease.

Conditions

• Congenital Heart Defects
• Underweight

Interventions

DIETARY_SUPPLEMENT

protocol

The energy and protein value of the prescribed diet will be followed according to the original protocol considering plans A, B or C, via a hypercaloric formula with a caloric density of 1kcal/ml for infants starting 60 days preoperatively. The return for nutritional monitoring will take place after evaluation: weekly, biweekly or monthly.

OTHER

Control

Afterwards, they will be evaluated through the standard nutritional protocol of the nutrition clinic of the Instituto de Cardiologia de and Hospital Santo Antonio de Porto Alegre, whose standard nutritional prescription is a polymeric formula with a caloric density of 0.67 kcal/ml. Nutritional monitoring will take place through telephone contact for information on the baby's clinical data and in person before the surgery is performed.

Sponsors & Collaborators

• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

  collaborator OTHER_GOV

• Irmandade Santa Casa de Misericórdia de Porto Alegre

  collaborator OTHER

• University Hospital Southampton NHS Foundation Trust

  collaborator OTHER

• Instituto de Cardiologia do Rio Grande do Sul

  lead OTHER

Principal Investigators

• Fernanda Lucchese, PhD · Instituto de Cardiologia do Rio Grande do Sul

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

30 Days

Max Age

12 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-09

Primary Completion

2024-04-02

Completion

2024-05-02