Early Physical Therapy Intervention in Preterm Infants

Not Applicable

Completed

• Conditions: Physical Therapy; Early Intervention; Preterm Infant; NICU; Motor Development; Home
• Interventions: Other: Usual Care; Other: Physical Therapy Early Intervention

• Registration Number: NCT03313427
• Lead Sponsor: University of Vic - Central University of Catalonia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-09
• Study First Submitted QC: 2017-10-12
• Study First Posted: 2017-10-18
• Study Start: 2017-12-01
• Status Verified: 2019-12
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01
• Last Update Submitted: 2019-12-06
• Last Update Posted: 2019-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Control	Usual Care	Usual care
Intervention	Physical Therapy Early Intervention	Usual care Early physical therapy intervention at the UCIN and after discharge, at home; based on the family-centered model.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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
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).
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.

Trial Locations

Locations (1)

Hospital Sant Joan de Deu; 🇪🇸 Barcelona, Spain