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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: fernandacec@ufcspa.edu.br
• Phone: + 55 51 998230-7733

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.