Early Intervention, Home, Motor Development, NICU, Physical Therapy, Preterm Infant
Conditions
Brief summary
The hypothesis of this study is that early physical therapy intervention, initiated during the NICU stay and up to 2 months corrected age, based on the family-centered model, could promote preterm infants motor development in short-term (2 months corrected age) and long-term (8 months corrected age). There is a high evidence level of different systematic reviews, which support the effectivity of early intervention with preterm infants. The principal aim of this randomized controlled trial is to evaluate the effectiveness of early physiotherapy intervention to promote motor development in preterm infants at 2 and 8 months corrected age. The secondary purpose is to study the motor development of those preterm infants who received early physical therapy intervention.
Interventions
OTHERPhysical Therapy Early Intervention
At the UCIN: * Parental education to empower them on motor development and parent-infant relationship. Consisted on 6 sessions during the first weeks at the NICU. * Tactile and kinaesthetic stimulation managed by parents. 2 times a day, 15 minutes each, during 10 days. At home: Psychomotor Development Program for the baby; comprised of different exercises, in different phases, depending on child maturation stage. Started after hospital discharge until 2 months corrected age.
OTHERUsual Care
NICU usual care
Sponsors
Hospital Sant Joan de Deu
University of Vic - Central University of Catalonia
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
28 Weeks to 34 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Preterm infants, gestational age between 28-34 weeks * Families with ability to take care of the child, without chronic or mental illness * Long-term parental presence in the hospital (at least 10h/day)
Exclusion criteria
* Children diagnosed with congenital disease or brain injury (LPV, HIV), before or during the study * Children undergoing major surgery (cardiac intervention, Ductus, thoracic intervention) * Children with musculoskeletal deformities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motor development. | 2 months corrected age and 8 months corrected age | Assessed by the Alberta Infant Motor Scale (AIMS). Total maximum score 40 points. Higher values represent a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Movement quality. | 40 weeks postmenstrual age and 2 months corrected age | Assessed by the General Movements Assessment. The assessment provide the quality of the movement (suboptimal/optimal/pathological). |
| Gross motor and fine motor function. | 8 months corrected age | Assessed by the Bayley Scale of Infant Development III. Percentile ranks from 1 to 99. Higher percentile represent a better outcome |
| Development and risk of development delay. | 1 months corrected age and 8 months corrected age | Assessed by the Ages and Stages Questionnaires Third Edition (ASQ-3). 30 questions covering 5 domains of development: communication, gross motor, fine motor, problem-solving and adaptive skills. |
| Mothers' stress index. | after the intervention, 3 months corrected age | Assessed by the Parents Stress Index - Short Form. Composed of 36 items with a Likert-type answer format of five options. |
Countries
Spain
Outcome results
None listed