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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Instituto de Cardiologia do Rio Grande do Sul

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Irmandade Santa Casa de Misericórdia de Porto Alegre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 16, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings