By InvitationNot Applicable

Telematic Support in Early Intervention on Infants At Risk of Neurodevelopmental Delays

Spain60 participantsStarted 2024-02-15

Plain-language summary

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.

Who can participate

Age range

3 Months – 12 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from Baseline in Motor Development on the Motor scale of the Infant Motor Development on the Bayley Scales of Infant and Toddler Development-III® (BSID-III) at month 2.

Timeframe: Baseline and Month 2.

Change from Baseline in maturation of motor skills on the Alberta Infant Motor Scale (AIMS) at month 2.

Timeframe: Baseline and Month 2.

Change from Baseline in infant motor behaviour and motor development on the Infant Motor Profile (IMP) at month 2.

Timeframe: Baseline and Month 2.

Trial details

NCT IDNCT06608576

SponsorUniversidad de Granada

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-31

View on ClinicalTrials.gov More High-risk Infants trials

Who can participate

Age range

3 Months – 12 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change from Baseline in Motor Development on the Motor scale of the Infant Motor Development on the Bayley Scales of Infant and Toddler Development-III® (BSID-III) at month 2.

Timeframe: Baseline and Month 2.

Change from Baseline in maturation of motor skills on the Alberta Infant Motor Scale (AIMS) at month 2.

Timeframe: Baseline and Month 2.

Change from Baseline in infant motor behaviour and motor development on the Infant Motor Profile (IMP) at month 2.

Timeframe: Baseline and Month 2.