Early Physical Therapy Intervention in Preterm Infants

University of Vic - Central University of Catalonia48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Preterm Infant Physical Therapy Early Intervention NICU

Interventions

Physical Therapy Early InterventionOTHER

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.

Usual CareOTHER

NICU usual care

Eligibility

Sex: ALLMin age: 28 WeeksMax age: 34 WeeksHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Motor development.

Assessed by the Alberta Infant Motor Scale (AIMS). Total maximum score 40 points. Higher values represent a better outcome.

Time frame: 2 months corrected age and 8 months corrected age

Secondary Outcomes

Movement quality.

Assessed by the General Movements Assessment. The assessment provide the quality of the movement (suboptimal/optimal/pathological).

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: after the intervention, 3 months corrected age