Early Physical Therapy Intervention in Preterm Infants

NCT03313427 | Completed

• 1 other identifier: PTNEO-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Infant; Physical Therapy; Early Intervention; NICU; Home; Motor Development

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Movement quality.

  40 weeks postmenstrual age and 2 months corrected age

• Gross motor and fine motor function.

  8 months corrected age

• Development and risk of development delay.

  1 months corrected age and 8 months corrected age

• Mothers' stress index.

  after the intervention, 3 months corrected age

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

OTHER

Usual care

Other: Usual Care

Interventions

Physical Therapy Early Intervention OTHER

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

Usual Care OTHER

NICU usual care

Control

Eligibility Criteria

• Age: 28 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vic - Central University of Catalonia: lead
• Hospital Sant Joan de Deu: collaborator

Study Sites (1)

Hospital Sant Joan de Deu

Barcelona, Spain

Location

Related Publications (1)

• 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.

  PMID: 35740832 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, MSc, PhD St.

Study Record Dates

• First Submitted: October 9, 2017
• First Posted: October 18, 2017
• Study Start: December 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 9, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)