Early Physical Therapy Intervention in Preterm Infants

Study Overview
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Brief Summary
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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.

Official Title
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Early Physical Therapy Intervention in Preterm Infants During the Stay in the Neonatal Intensive Care Unit and at Home to Promote Motor Development

Conditions
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Preterm Infant, Physical Therapy, Early Intervention, NICU, Home, Motor Development

Intervention / Treatment
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* Other: Physical Therapy Early Intervention
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 28 Weeks
Maximum Age: 34 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Usual care Early physical therapy intervention at the UCIN and after discharge, at home; based on the family-centered model. | Other: Physical Therapy Early Intervention<br>* 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.<br>|
| Other: Control<br>Usual care | Other: Usual Care<br>* NICU usual care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor development. | Assessed by the Alberta Infant Motor Scale (AIMS). Total maximum score 40 points. Higher values represent a better outcome. | 2 months corrected age and 8 months corrected age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Movement quality. | Assessed by the General Movements Assessment. The assessment provide the quality of the movement (suboptimal/optimal/pathological). | 40 weeks postmenstrual age and 2 months corrected age | 
| Gross motor and fine motor function. | Assessed by the Bayley Scale of Infant Development III. Percentile ranks from 1 to 99. Higher percentile represent a better outcome | 8 months corrected age | 
| Development and risk of development delay. | 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. | 1 months corrected age and 8 months corrected age | 
| Mothers' stress index. | Assessed by the Parents Stress Index - Short Form. Composed of 36 items with a Likert-type answer format of five options. | after the intervention, 3 months corrected age |