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

Sponsor

Instituto de Cardiologia do Rio Grande do Sul (Other)

Overall Status

Recruiting

CT.gov ID

NCT05907109

Collaborator

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. (Other), Irmandade Santa Casa de Misericórdia de Porto Alegre (Other)

300

Enrollment

Locations

Arms

57.5

Anticipated Duration (Months)

150

Patients Per Site

2.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Heart Disease Child Development Early Intervention	Behavioral: Remotely monitored parent-mediated hybrid home and clinic based multidisciplinary Early Intervention protocols.	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective Multicentric single-blinded, Two-arm Randomized Clinical TrialProspective Multicentric single-blinded, Two-arm Randomized Clinical Trial

Masking:

Single (Outcomes Assessor)

Masking Description:

Assessors blinded to the allocation of participants

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 16, 2021

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Compose the Neuropsychomotor profile of babies with CHD in multidisciplinary outpatient follow-up and compare to the group without follow-up. [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).

Secondary Outcome Measures

Neurodevelopment Scores in infant with CHD (Bayley Scales of Infant and Toddler Development- Third Edition) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 2 Months

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Irmandade Santa Casa de Misericórdia de Porto Alegre	Porto Alegre	Rio Grande Do Sul	Brazil	90035-190
2	Instituto de Cardiologia	Porto Alegre	Rio Grande Do Sul	Brazil	90620-001.