Early Physical Therapy Intervention in Preterm Infants
Primary Purpose
Preterm Infant, Physical Therapy, Early Intervention
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Physical Therapy Early Intervention
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Preterm Infant
Eligibility Criteria
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
Sites / Locations
- Hospital Sant Joan de Deu
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention
Control
Arm Description
Usual care Early physical therapy intervention at the UCIN and after discharge, at home; based on the family-centered model.
Usual care
Outcomes
Primary Outcome Measures
Motor development.
Assessed by the Alberta Infant Motor Scale (AIMS). Total maximum score 40 points. Higher values represent a better outcome.
Secondary Outcome Measures
Movement quality.
Assessed by the General Movements Assessment. The assessment provide the quality of the movement (suboptimal/optimal/pathological).
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
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.
Mothers' stress index.
Assessed by the Parents Stress Index - Short Form. Composed of 36 items with a Likert-type answer format of five options.
Full Information
NCT ID
NCT03313427
First Posted
October 9, 2017
Last Updated
December 6, 2019
Sponsor
University of Vic - Central University of Catalonia
Collaborators
Hospital Sant Joan de Deu
1. Study Identification
Unique Protocol Identification Number
NCT03313427
Brief Title
Early Physical Therapy Intervention in Preterm Infants
Official Title
Early Physical Therapy Intervention in Preterm Infants During the Stay in the Neonatal Intensive Care Unit and at Home to Promote Motor Development
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vic - Central University of Catalonia
Collaborators
Hospital Sant Joan de Deu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infant, Physical Therapy, Early Intervention, NICU, Home, Motor Development
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Usual care Early physical therapy intervention at the UCIN and after discharge, at home; based on the family-centered model.
Arm Title
Control
Arm Type
Other
Arm Description
Usual care
Intervention Type
Other
Intervention Name(s)
Physical Therapy Early Intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
NICU usual care
Primary Outcome Measure Information:
Title
Motor development.
Description
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 Outcome Measure Information:
Title
Movement quality.
Description
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
Title
Gross motor and fine motor function.
Description
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
Title
Development and risk of development delay.
Description
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
Title
Mothers' stress index.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
28 Weeks
Maximum Age & Unit of Time
34 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital Sant Joan de Deu
City
Barcelona
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35740832
Citation
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.
Results Reference
derived
Learn more about this trial
Early Physical Therapy Intervention in Preterm Infants
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