Congenital Heart Defects Clinical Trial
Official title:
Nutrition In Preoperative Pediatric Congenital Heart Disease: A Randomized Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 118 |
Est. completion date | May 2, 2024 |
Est. primary completion date | April 2, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Days to 12 Months |
Eligibility | Inclusion Criteria: - 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; Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Instituto de Cardiologia do Rio Grande do Sul | Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Irmandade Santa Casa de Misericórdia de Porto Alegre, University Hospital Southampton NHS Foundation Trust |
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01671566 -
Interval Training in Adults With Congenital Heart Disease a Randomized Trial
|
N/A | |
Recruiting |
NCT01421030 -
Outcomes in Patients and Their Closest Relatives Treated for Congenital Heart Disease With Catheter Based or Surgical Techniques
|
Phase 0 | |
Withdrawn |
NCT00981591 -
Inhaled Iloprost as an Adjunct to Inhaled Nitric Oxide in Pediatric Critical Care Patients
|
Phase 1/Phase 2 | |
Completed |
NCT01567579 -
An Evaluation of Routine Developmental Follow-Up in Infants and Children With Congenital Heart Disease
|
||
Terminated |
NCT00208676 -
Using Tissue Doppler/Synchronization to Determine Heart Function in Children With Congenital Heart Disease
|
N/A | |
Completed |
NCT01941576 -
Effects of rhBNP in Pediatrics After Corrective Repair of Tetralogy Of Fallot
|
N/A | |
Completed |
NCT01475357 -
Intestinal Function in Neonates With Complex Congenital Heart Disease
|
N/A | |
Active, not recruiting |
NCT01227096 -
Randomized Controlled Trial of the Effects of Electroacupuncture Preconditioning in Children Undergoing Cardiac Surgery
|
N/A | |
Completed |
NCT01201486 -
Use of Color Doppler in Routine Examination of Fetal Heart in Second Trimester
|
N/A | |
Completed |
NCT00397514 -
Assessing the Hemodynamic Benefits of Cardiac Resynchronization Therapy in Children Following Open-Heart Surgery
|
N/A | |
Completed |
NCT02232399 -
Is Levosimendan Superior to Milrinone Regarding Acute Kidney Injury After Cardiac Surgery for Congenital Heart Disease?
|
Phase 2 | |
Completed |
NCT05191654 -
Investigation of Cardiopulmonary Parameters, Motor Development and Muscle Strength in DS With and Without CHD
|
||
Recruiting |
NCT06267859 -
Development of Methods for Effective Treatment and Improvement of Common Somatic Diseases in Children
|
Early Phase 1 | |
Completed |
NCT02320669 -
Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass
|
Phase 3 | |
Completed |
NCT01489475 -
Plasma Angiopoietin Levels in Children Following Cardiopulmonary Bypass
|
N/A | |
Withdrawn |
NCT00579358 -
Molecular Basis of Congenital Heart Defects
|
||
Recruiting |
NCT01196182 -
Congenital Heart Disease GEnetic NEtwork Study (CHD GENES)
|
||
Recruiting |
NCT04382573 -
Better Delineation of CDK13 Related Phenotype and Epigenetic Signature.
|
||
Recruiting |
NCT03822442 -
MRI to Predict Rejection and Failure in Transplant and Cardiomyopathy Patients
|
||
Completed |
NCT00450684 -
Cardiac Resynchronization Therapy in Congenital Heart Defects
|
Phase 2/Phase 3 |