Nutrition In Preoperative Pediatric Congenital Heart Disease
1 other identifier
interventional
118
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2022
CompletedFirst Posted
Study publicly available on registry
July 14, 2022
CompletedStudy Start
First participant enrolled
January 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 2, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 2, 2024
CompletedJuly 14, 2022
July 1, 2022
1.2 years
March 18, 2022
July 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
changing the nutritional status
Effectiveness of the cross-culturally adapted protocol on changing the nutritional status of babies with congenital heart disease
change in nutritional status after 60 days of preoperative intervention
Study Arms (2)
Intervention group
EXPERIMENTALIn the first evaluation and after the patient's consent, a standardized complementary questionnaire will be applied, with demographic and clinical information. The nutritionist will carry out the anthropometric assessment, questionnaires and application of the protocol for this group. 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.
Control group
OTHERIn the first evaluation and after the patient's consent, a standardized complementary questionnaire will be applied, with demographic and clinical information. The nutritionist will carry out the anthropometric assessment and questionnaires. Afterwards, they will be evaluated through the standard nutritional protocol of the nutrition clinic of the Institute of Cardiology and Children's Hospital Santo Antonio of 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Children with a diagnosis of congenital heart disease aged between zero and twelve months, awaiting surgery for cardiac correction, classified in risk category 1 of the RACHS-1 score;
- Term birth;
You may not qualify if:
- Patients with:
- Neurological impairment;
- Craniofacial malformation;
- Structural alterations of the upper airways;
- Respiratory impairment;
- Suspicion or diagnosis of genetic syndrome;
- Any type of food allergy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Marino LV, Johnson MJ, Hall NJ, Davies NJ, Kidd CS, Daniels ML, Robinson JE, Richens T, Bharucha T, Darlington AE; British Dietetic Association Paediatric Cardiology Interest Group. The development of a consensus-based nutritional pathway for infants with CHD before surgery using a modified Delphi process. Cardiol Young. 2018 Jul;28(7):938-948. doi: 10.1017/S1047951118000549. Epub 2018 Apr 29.
PMID: 29704905BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fernanda Lucchese, PhD
Instituto de Cardiologia do Rio Grande do Sul
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Due to the nature of the intervention, full blinding will not be possible. However, the statistical analysis team will be blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PHD
Study Record Dates
First Submitted
March 18, 2022
First Posted
July 14, 2022
Study Start
January 9, 2023
Primary Completion
April 2, 2024
Study Completion
May 2, 2024
Last Updated
July 14, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share