Early Physical Therapy Intervention in Preterm Infants

Preterm Infant Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03313427
• Other study ID #: PTNEO-001
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: December 1, 2019

Study information

• Verified date: December 2019
• Source: University of Vic - Central University of Catalonia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 28 Weeks to 34 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Early Intervention
• Home
• Motor Development
• NICU
• Physical Therapy
• Premature Birth
• Preterm Infant

Intervention

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.
• Usual Care
NICU usual care

Locations

Country	Name	City	State
Spain	Hospital Sant Joan de Deu	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
University of Vic - Central University of Catalonia	Hospital Sant Joan de Deu

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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