Early Physical Therapy Intervention in Preterm Infants

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

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 Overview

• Status: Completed
• Conditions: Physical Therapy; Preterm Infant; Early Intervention; Motor Development; NICU; Home
• Intervention / Treatment: Other: Physical Therapy Early Intervention; Other: Usual Care

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Hospital Sant Joan de Deu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 7 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; 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.
Other: Control; Usual care	Other: Usual Care; NICU usual care

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Vic - Central University of Catalonia
• Collaborators: Hospital Sant Joan de Deu

Publications and helpful links

General Publications

• Ochandorena-Acha M, Terradas-Monllor M, Lopez Sala L, Cazorla Sanchez ME, Fornaguera Marti M, Munoz Perez I, Agut-Quijano T, Iriondo M, Casas-Baroy JC. Early Physiotherapy Intervention Program for Preterm Infants and Parents: A Randomized, Single-Blind Clinical Trial. Children (Basel). 2022 Jun 15;9(6):895. doi: 10.3390/children9060895.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: October 9, 2017
• First Submitted That Met QC Criteria: October 12, 2017
• First Posted (Actual): October 18, 2017

Study Record Updates

• Last Update Posted (Actual): December 9, 2019
• Last Update Submitted That Met QC Criteria: December 6, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: PTNEO-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No