Actively Recruiting
Analysis of the Impact of Different Intervention Models on the Neuropsychomotor Development of Premature Infants Based on the ICF Biopsychosocial Model
Led by Federal University of Health Science of Porto Alegre · Updated on 2025-06-25
60
Participants Needed
1
Research Sites
32 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Prematurity is an important risk factor for delays in neuropsychomotor development, which can affect a baby's functional abilities. This research aims to analyze how different intervention models based on the International Classification of Functioning (ICF) biopsychosocial model impact the neuropsychomotor development of premature infants. The study focuses on babies born before 37 weeks of gestation, assessing their development from corrected ages of 4 months up to 24 months. Participants are divided into two groups: one receiving only guidance for families through monthly phone calls and weekly reminders, and another receiving both professional stimulation sessions and family guidance. The professional stimulation involves sessions lasting about 50 minutes with exercises in various positions tailored to the baby's neuropsychomotor development and corrected age, with frequency depending on prematurity level. Both groups receive printed guides and age-appropriate toys to support stimulation at home. Assessments occur at 4, 8, 12, and 24 months corrected age. Throughout the study, families will regularly stimulate their babies at home and report frequency. Evaluations include neuropsychomotor development measured by the Bayley Infant and Toddler Development Scales, cognitive assessment with the Montreal Cognitive Assessment, home environment quality, quality of life, and socioeconomic factors. Researchers will maintain contact via phone for guidance and support. The total participation duration extends to 24 months corrected age, with safety and progress closely monitored.
CONDITIONS
Brief Title
Different Intervention Models of Premature Infants Based on the ICF Biopsychosocial Model
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Gestational age less than 37 weeks
- Corrected age between 4 and 12 months (with a one and a half month window) and at 24 months (four months window)
- Babies registered at the High Risk Outpatient Clinic of the UCS Clinical Center
- Authorization from the child's legal guardian by signing the Free and Informed Consent Form (TCLE)
You will not qualify if you...
- Not meeting the inclusion criteria
- Having neurological diseases
- Presence of acute diseases such as pneumonia, bronchiolitis, or trauma
- Musculoskeletal alterations
- Genetic syndromes or undergoing genetic investigation
- Heart diseases requiring surgical intervention
- Untreated congenital torticollis
- Congenital clubfoot
- Cerebral hemorrhage grade IV
- Missing first and/or last evaluation
- Incomplete evaluations
- Convulsive crises during the study period
- Participation in other intervention programs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From 4 to 12 corrected months
Participants receive either monthly telephone orientations with weekly reminders or professional stimulation sessions combined with family orientations based on the baby's corrected age and degree of prematurity. Families also perform daily stimulation at home following guidance provided.
3 evaluation visits approximately every 4 months and monthly phone contacts; professional stimulation sessions occur 1 to 8 times per month depending on prematurity for the stimulation group
Duration - Up to 24 corrected months
Participants continue to be assessed at 24 months corrected age to evaluate neuropsychomotor development and other outcomes.
1 evaluation visit around 24 months corrected age
Trial Site Locations
Total: 1 location
1
Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA)
Porto Alegre, Rio Grande do Sul, Brazil, 90050170
Actively Recruiting
Research Team
F
Fernanda Cechetti, Full professor
T
Tatiane Paludo, PhD Student
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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