Telematic Support in Early Intervention on Infants At Risk of Neurodevelopmental Delays (BBL-ATOP)

University of Granada (UGR)

Status: Invitation-only

Conditions: High-risk Infants

Treatments: Other: Face-to-face standard treatment; Other: Telematic Support

Study type: Interventional

Funder types: Other

Identifiers

NCT06608576

BBL-ATPO-2023

Details and patient eligibility

About

The purpose of this study is to evaluate the effects of early intervention support sessions via video conferencing as an adjuvant option to motor development on infants at risk of neurodevelopmental delays or disorders.

Full description

The parents will be informed about the procedure and will be given a written informed consent in order to participate in the study. Then, the families will be randomized into one of two groups: standard treatment or telematic support. Both treatments in a 2-month period.

Enrollment: 60 estimated patients

Sex: All

Ages: 3 to 12 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Minor infants with a chronological or corrected age of 3 to 12 months and their parents attending physical therapy early intervention protocol at the Neuropediatrics and Neurodevelopment Unit of San Cecilio University Hospital in Granada.
• At risk of neurodevelopmental delays or disorders.
• Whose family has a cell phone with WhatsApp Application installed and internet to be able to carry out the telematic tests.

Exclusion criteria

• Independent walking children.
• Minor infants with diagnosis of neuromotor injury, visual and auditory sensory disorders or congenital anomalies.
• Infants with orthoses and/or prostheses.
• Children with health complications that enable the child's participation in the study.
• Not spanish-speaking parents.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Standard Treatment

Active Comparator group

Description:

participants will receive face-to-face early intervention treatment on physical therapy area once a month for two months.

Treatment:

Other: Face-to-face standard treatment

Telematic Support

Experimental group

Description:

Participants will receive weekly telematic early intervention sessions at home via video conferencing for two months.

Treatment:

Other: Telematic Support