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NeuroCardio Baby Research Outpatient Clinic: Study on the Neurodevelopment of Infants With Congenital Heart Disease in Brazil

Primary Purpose

Congenital Heart Disease, Child Development, Early Intervention

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Remotely monitored parent-mediated hybrid home and clinic based multidisciplinary Early Intervention protocols.
Sponsored by
Instituto de Cardiologia do Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Heart Disease focused on measuring Congenital Heart Disease, Child Development, Early Intervention, Telemonitoring, Home-based intervention

Eligibility Criteria

undefined - 2 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Pregnant women with a fetal diagnosis of CHD Child up to two months diagnosed with CHD Signature of the electronic free and informed consent form by those parents or legal guardians. Exclusion Criteria: Psychiatric or neurocognitive condition that prevents obtaining reliable clinical data (defined by the clinical judgment of the investigators) Inability to read by parents or legal guardians.

Sites / Locations

  • Irmandade Santa Casa de Misericórdia de Porto AlegreRecruiting
  • Instituto de CardiologiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control Group - Standart of Care

Arm Description

Remotely monitored parent-mediated hybrid home and clinic based multidisciplinary Early Intervention protocols.

The control group receives basic guidelines on child development, nutrition, and breastfeeding provided by the Brazilian Ministry of Health, in addition to standard of care cardiac pediatric follow-up visits. Infants will receive outcome developmental evaluations within a 42-month follow-up clinic.

Outcomes

Primary Outcome Measures

Compose the Neuropsychomotor profile of babies with CHD in multidisciplinary outpatient follow-up and compare to the group without follow-up.
Compose the Neuropsychomotor profile of babies with CHD in multidisciplinary outpatient follow-up and compare to the group without follow-up using Bayley Scales of Infant and Toddler Development- Third Edition).

Secondary Outcome Measures

Neurodevelopment Scores in infant with CHD (Bayley Scales of Infant and Toddler Development- Third Edition)
Amercian Heart Association recommends surveillance, screening, evaluation in the nerudovelopment in pediatric congenital heart disease (CHD) population. The Bayley Scales of Infant and Toddler Development- Third Edition is a recognized scale the assessment the Infant Neudevelopment in cognitive, language and motor domains.

Full Information

First Posted
June 8, 2023
Last Updated
June 8, 2023
Sponsor
Instituto de Cardiologia do Rio Grande do Sul
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Irmandade Santa Casa de Misericórdia de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT05907109
Brief Title
NeuroCardio Baby Research Outpatient Clinic: Study on the Neurodevelopment of Infants With Congenital Heart Disease in Brazil
Official Title
NeuroCardio Baby Research Outpatient Clinic: Study on the Neurodevelopment of Infants With Congenital Heart Disease in Brazil
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto de Cardiologia do Rio Grande do Sul
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Irmandade Santa Casa de Misericórdia de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this randomized clinical trial is to test the effectiveness of a low-cost hybrid remotely monitored parent-mediated and clinic-based multidisciplinary early intervention (EI) for low-income infants with CHD in Brazil. The intervention protocols will be administered according to age modules, families will be monitored weekly. High risk infants also receive supplemental clinic-based interventions according to developmental needs. Controls will receive standard of care and access to early child development and nutrition practices information from the Brazilian Ministry of Health. All infants will be evaluated at within a 42-month follow-up research outpatient clinic, called NeuroCardio Baby at Santo Antonio Pediatric Hospital, of the Santa Casa de Misericordia Hospital Complex, and affiliated with The Cardiology Institute-University Foundation of Cardiology (IC-FUC), Porto Alegre, Brazil.
Detailed Description
The objective of this randomized clinical trial is to develop low-cost hybrid remotely monitored parent-mediated multidisciplinary early intervention (EI) protocols for infants with CHD in Brazil. The protocols will be conducted via parents at home according to age modules (0- 3m, 3-6m, 6-9m, and 9-12m), and families will be monitored by clinical researchers weekly. High risk infants will receive supplemental EI services at the clinic according to developmental needs. Infants will receive outcome evaluations within a 42-month follow-up clinic. The aim of this study is to prevent or reduce neurodevelopmental sequelae and developmental delays associated with CHD. Participants in the intervention group receive multidisciplinary EIs in Nutrition (including breastfeeding support), Speech and Language Therapy for tube feeding transition, feeding readiness, and language and motor development and early stimulation for global development in cognitive, language and motor skills according to age milestones. Premature infants will receive age-corrected protocols and evaluations. Caregivers will receive psychological and protocol administration support. The control group receives basic child development, nutrition, and breastfeeding information provided by the Brazilian Ministry of Health, in addition to standard of care cardiac pediatric follow-up visits. Neurodevelopment is assessed with the Brazilian Version of Bayley Developmental Scale for Infants and Toddlers (3rd edition) in both groups, at 6, 12, 24, and 36-42 months. Nutritional outcomes, such as ml of breastmilk drown by mothers, and infant weight and length are measured. The study will compare the developmental outcome scores and parental quality of life scores of the intervention and control groups during the intervention (6 and 12months) and at 1 and 2 years follow up. We believe that infants with CHD who receive monitoring and early multidisciplinary interventions in the first year of life have better neurodevelopmental outcomes than infants who do not receive early multidisciplinary care. In Brazil, access to EI services is extremely limited to urban centers and higher income families. Infants from low-income backgrounds and rural settings are likely to be left without services during early childhood. Our remote, low-cost intervention aims at increasing access to EI for Brazilian infants with CHD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease, Child Development, Early Intervention
Keywords
Congenital Heart Disease, Child Development, Early Intervention, Telemonitoring, Home-based intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective Multicentric single-blinded, Two-arm Randomized Clinical Trial
Masking
Outcomes Assessor
Masking Description
Assessors blinded to the allocation of participants
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Remotely monitored parent-mediated hybrid home and clinic based multidisciplinary Early Intervention protocols.
Arm Title
Control Group - Standart of Care
Arm Type
No Intervention
Arm Description
The control group receives basic guidelines on child development, nutrition, and breastfeeding provided by the Brazilian Ministry of Health, in addition to standard of care cardiac pediatric follow-up visits. Infants will receive outcome developmental evaluations within a 42-month follow-up clinic.
Intervention Type
Behavioral
Intervention Name(s)
Remotely monitored parent-mediated hybrid home and clinic based multidisciplinary Early Intervention protocols.
Intervention Description
Parents receive manualized protocols, instructional videos, and toy and material kits to administer EIs at home. New modules are provided according to infant age or stage of intervention during the length of brief interventions or 12-months. The families will be monitored by clinical researchers weekly. -High risk infants will receive supplemental EI services at the clinic according to developmental needs. Infants will receive outcome evaluations within a 42-month follow-up clinic.
Primary Outcome Measure Information:
Title
Compose the Neuropsychomotor profile of babies with CHD in multidisciplinary outpatient follow-up and compare to the group without follow-up.
Description
Compose the Neuropsychomotor profile of babies with CHD in multidisciplinary outpatient follow-up and compare to the group without follow-up using Bayley Scales of Infant and Toddler Development- Third Edition).
Time Frame
From six months of age
Secondary Outcome Measure Information:
Title
Neurodevelopment Scores in infant with CHD (Bayley Scales of Infant and Toddler Development- Third Edition)
Description
Amercian Heart Association recommends surveillance, screening, evaluation in the nerudovelopment in pediatric congenital heart disease (CHD) population. The Bayley Scales of Infant and Toddler Development- Third Edition is a recognized scale the assessment the Infant Neudevelopment in cognitive, language and motor domains.
Time Frame
From six months of age

10. Eligibility

Sex
All
Maximum Age & Unit of Time
2 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pregnant women with a fetal diagnosis of CHD Child up to two months diagnosed with CHD Signature of the electronic free and informed consent form by those parents or legal guardians. Exclusion Criteria: Psychiatric or neurocognitive condition that prevents obtaining reliable clinical data (defined by the clinical judgment of the investigators) Inability to read by parents or legal guardians.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fernanda Lucchese-Lobato, PHD
Phone
+1(646)8304997
Email
luccheselobato@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernanda Lucchese-Lobato, PHD
Organizational Affiliation
Instituto De Cardiologia/Fundação Universitária De Cardiologia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Irmandade Santa Casa de Misericórdia de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-190
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rita C Michelon
Phone
51989055917
Email
cassimichelon@gmail.com
Facility Name
Instituto de Cardiologia
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90620-001.
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rita C Michelon
Phone
51989055917
Email
cassimichelon@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
22851541
Citation
Marino BS, Lipkin PH, Newburger JW, Peacock G, Gerdes M, Gaynor JW, Mussatto KA, Uzark K, Goldberg CS, Johnson WH Jr, Li J, Smith SE, Bellinger DC, Mahle WT; American Heart Association Congenital Heart Defects Committee, Council on Cardiovascular Disease in the Young, Council on Cardiovascular Nursing, and Stroke Council. Neurodevelopmental outcomes in children with congenital heart disease: evaluation and management: a scientific statement from the American Heart Association. Circulation. 2012 Aug 28;126(9):1143-72. doi: 10.1161/CIR.0b013e318265ee8a. Epub 2012 Jul 30.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/22851541/
Description
Neurodevelopmental outcomes in children with congenital heart disease: evaluation and management: a scientific statement from the American Heart Association

Learn more about this trial

NeuroCardio Baby Research Outpatient Clinic: Study on the Neurodevelopment of Infants With Congenital Heart Disease in Brazil

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