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

June 8, 2023 updated by: Fernanda Lucchese, Instituto de Cardiologia do Rio Grande do Sul
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-190
        • Recruiting
        • Irmandade Santa Casa de Misericordia de Porto Alegre
        • Contact:
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90620-001.
        • Recruiting
        • Instituto de Cardiologia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Remotely monitored parent-mediated hybrid home and clinic based multidisciplinary Early Intervention protocols.
Behavioral: Remotely monitored parent-mediated hybrid home and clinic based multidisciplinary Early Intervention protocols.
  • 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.
No Intervention: Control Group - Standart of Care
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compose the Neuropsychomotor profile of babies with CHD in multidisciplinary outpatient follow-up and compare to the group without follow-up.
Time Frame: From six months of age
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).
From six months of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurodevelopment Scores in infant with CHD (Bayley Scales of Infant and Toddler Development- Third Edition)
Time Frame: From six months of age
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.
From six months of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Investigators

  • Principal Investigator: Fernanda Lucchese-Lobato, PHD, Instituto De Cardiologia/Fundação Universitária De Cardiologia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

June 8, 2023

First Submitted That Met QC Criteria

June 8, 2023

First Posted (Estimated)

June 16, 2023

Study Record Updates

Last Update Posted (Estimated)

June 16, 2023

Last Update Submitted That Met QC Criteria

June 8, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4864543

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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