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Completed

NCT Number: NCT03313427

Early Physical Therapy Intervention in Preterm Infants

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.

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Key information

Conditions

Preterm Infant Early Intervention Female Urogenital Diseases and Pregnancy Complications Home Motor Development NICU Obstetric Labor Complications Obstetric Labor, Premature Physical Therapy Pregnancy Complications Premature Birth Urogenital Diseases

Age range

28 week–34 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Sant Joan de Deu

Barcelona, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Usual Care

Other

NICU usual care

Primary outcomes

  1. Motor development.

    Time frame: 2 months corrected age and 8 months corrected age

    Assessed by the Alberta Infant Motor Scale (AIMS). Total maximum score 40 points. Higher values represent a better outcome.

Secondary outcomes

  1. Movement quality.

    Time frame: 40 weeks postmenstrual age and 2 months corrected age

    Assessed by the General Movements Assessment. The assessment provide the quality of the movement (suboptimal/optimal/pathological).

  2. Gross motor and fine motor function.

    Time frame: 8 months corrected age

    Assessed by the Bayley Scale of Infant Development III. Percentile ranks from 1 to 99. Higher percentile represent a better outcome

  3. Development and risk of development delay.

    Time frame: 1 months corrected age and 8 months corrected age

    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.

  4. Mothers' stress index.

    Time frame: after the intervention, 3 months corrected age

    Assessed by the Parents Stress Index - Short Form. Composed of 36 items with a Likert-type answer format of five options.

Sponsors and collaborators

Lead sponsor

University of Vic - Central University of Catalonia

Other

Collaborators

  • Hospital Sant Joan de Deu

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 18, 2017
Registry last updated
Dec 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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