Different early-intervention models for premature infants using the ICF biopsychosocial approach

Analysis of the Impact of Different Intervention Models on the Neuropsychomotor Development of Premature Infants Based on the ICF Biopsychosocial Model

This project will test whether different early-intervention approaches based on the ICF biopsychosocial model help improve neuropsychomotor development in babies born premature.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 4 Months to 2 Years
• Sex: All
• Sponsor: Federal University of Health Science of Porto Alegre (Academic / other)
• Locations: 1 site (Porto Alegre, Rio Grande do Sul)
• Trial ID: NCT05989438 on ClinicalTrials.gov

What this trial studies

Premature infants seen at the UFCSPA High Risk Outpatient Clinic are randomized to receive either family-guidance only or therapist-led stimulation plus family guidance using the ICF biopsychosocial framework. Participants are enrolled between corrected ages of about 4 to 12 months and followed with evaluations through roughly 24 months corrected age. The trial focuses on functional neuropsychomotor outcomes and uses standardized developmental and functional measures to compare the two intervention models. The aim is to standardize approaches to early intervention that prioritize functionality and family support.

Who should consider this trial

Good fit: Ideal candidates are infants born before 37 weeks gestation who are registered at the UFCSPA High Risk Outpatient Clinic, are between about 4 and 12 months corrected age at enrollment, and whose caregivers provide informed consent.

Not a fit: Infants with major neurological injury (e.g., grade IV hemorrhage), genetic syndromes, significant cardiac or musculoskeletal conditions, uncontrolled seizures, or those unable to complete baseline and final evaluations are unlikely to benefit from these specific interventions.

Why it matters

Potential benefit: If successful, the interventions could lead to more targeted early-intervention programs that improve motor skills and everyday functioning for premature infants.

How similar studies have performed: Family-centered early intervention and physiotherapy approaches have shown benefit for preterm motor development in prior work, but randomized interventions explicitly framed and reported using the ICF biopsychosocial model remain limited.

Eligibility criteria

Inclusion Criteria:

* 1\. Gestational age less than 37 weeks, corrected age between 4 and 12 months (one and a half month window) and at 24 months (four months window)
* Babies from the High Risk Outpatient Clinic of the UCS Clinical Center, registered there;
* Authorization of those responsible for the minor consenting to participation in the study by signing the Free and Informed Consent Form (TCLE).

Exclusion Criteria:

* All those subjects who do not follow the items mentioned above;
* Presenting neurological diseases;
* Presence of acute diseases (eg pneumonia, bronchiolitis, trauma)
* Musculoskeletal alterations;
* Genetic syndromes;
* In genetic investigation;
* Heart diseases with indication for surgical intervention;
* Untreated congenital torticollis;
* Congenital clubfoot;
* Cerebral hemorrhage grade IV
* Those who do not undergo the first and/or last evaluation;
* Incomplete evaluation;
* Convulsive crisis during study period;
* Participants from other intervention programs.

Where this trial is running

Porto Alegre, Rio Grande do Sul

• Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA) — Porto Alegre, Rio Grande do Sul, Brazil (Recruiting)

Study contacts

• Study coordinator: Fernanda Cechetti, Full professor

Conditions Prematurity; Physiotherapy; CIF; Child development; Early Intervention