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Early Physical Therapy Intervention in Preterm Infants

NCT ID: NCT03313427

Last Updated: 2019-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2019-12-01

Brief Summary

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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

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Conditions

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Preterm Infant Physical Therapy Early Intervention NICU Home Motor Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Intervention

Usual care Early physical therapy intervention at the UCIN and after discharge, at home; based on the family-centered model.

Group Type EXPERIMENTAL

Physical Therapy Early Intervention

Intervention Type 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.

Control

Usual care

Group Type OTHER

Usual Care

Intervention Type OTHER

NICU usual care

Interventions

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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.

Intervention Type OTHER

Usual Care

NICU usual care

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

28 Weeks

Maximum Eligible Age

34 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Sant Joan de Deu

OTHER

Sponsor Role collaborator

University of Vic - Central University of Catalonia

OTHER

Sponsor Role lead

Responsible Party

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Mirari Ochandorena Acha

Physiotherapist, MSc, PhD St.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Sant Joan de Deu

Barcelona, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 35740832 (View on PubMed)

Other Identifiers

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PTNEO-001

Identifier Type: -

Identifier Source: org_study_id