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Completed

NCT Number: NCT01089296

The Norwegian Physical Therapy Study in Preterm Infants

This is a pragmatic randomized controlled study. The purpose of the study is to evaluate the practice and effect of customised physiotherapy on preterm infants'motor development when the intervention is performed over a period of three weeks while the infant resides in the neonatal intensive care unit. The study will also attempt to analyze the parents' experiences in being actively involved in education and practice of the intervention designed to promote the child's motor development, and the effects on the parent-child relationship in the short and long term.The children are followed up until a corrected age of two years. This study consists of a pragmatic randomized controlled trial and a qualitative study.

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Key information

Conditions

Movement Disorders Central Nervous System Diseases Nervous System Diseases

Age range

7 day–10 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of North Norway

Tromsø, Troms, 9013, Norway

About this study

Infants born preterm with an gestational age below 32 weeks have an increased risk of developing different grades and types of abnormalities, among them delayed motor development, co-ordination difficulties and cerebral palsy. The prevalence of serious developmental abnormalities increases the lower the gestational age and birth weight. The reported incidence of mild developmental abnormalities is 15-20 % in children with a gestational age <28 weeks or with a birth weight under 1000 g, 10-20 % in children with a gestational age of 28-31 weeks or a birth weight between 1000-1500 g and only 5 % in children born at term. The incidence of cerebral palsy is 10-20% amongst children in the first group, 5-10% in the second group and only 0,1 % in children born at term.With such a high risk of developing motor abnormalities for infants born preterm together with limited evidence-based knowledge of early physiotherapy approaches that facilitate motor development, it is essential that more research is done in this area to ensure that physiotherapy if used, is in the right manner to prevent and reduce such difficulties.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Child born before or at 32nd gestational week.
  • Child that tolerates being handled at 34th week postmenstrual age.
  • Parents that can perform the intervention understand and speak Norwegian.
  • Follow up of the child in the hospital where the intervention is given.

Exclusion criteria

  • Child born later than 32nd week.
  • Child who cannot tolerate being handled for up to 10 minutes at 34th postmenstrual age.
  • Triplets or more.
  • Child who has undergone surgery.
  • Child with large deformities.
  • Parents that can perform the intervention but do not understand and speak Norwegian.
  • Follow up of the child is not taking place in the hospital where the intervention is given.
  • All children who fill the inclusion criteria will be included to begin with.
  • If at a later stage they are unable to manage the tests due to their condition they will be excluded.

Treatment and study plan

Individually customized physiotherapy

Other

Main elements in the intervention are postural support and facilitating techniques. The intervention will be carried out twice a day over a three-week period if the infant's condition allows it. The length of each treatment session will be adjusted dependent on the infant's response and condition. Maximum treatment time is 10 minutes.

Other names: Physiotherapy, Physical Therapy, Premature birth, Early Intervention

Primary outcomes

  1. Peabody Developmental Motor Scales(PDMS-2)

    Time frame: Two years post term age

    PDMS-2 assess both fine- and gross motor function. Even though our Primary Outcome Measure is at two years post term age, we are going to publish results from assessments at earlier ages when they exist for the whole sample as the study proceeds.

Secondary outcomes

  1. Test of Infant Motor Performance Screening Items (TIMPSI), General Movement Assessment (GMA),Test of Infant Motor Performance(TIMP), Alberta Infant Motor Scale (AIMS), Peabody Developmental Motor Scales (PDMS-2)

    Time frame: TIMPSI: 34 w (baseline). GMA: 34 w, 36 w, 3 mo. TIMP: 37 w, 3 mo. AIMS: 3 mo, 6 mo, 12 mo. PDMS-2: 6 mo, 12 mo, 24 mo.

    Results from the different Time Frames will be published successively as the project proceeds.

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Collaborators

  • Oslo University Hospital
  • St. Olavs Hospital
  • University of Illinois at Chicago
  • University of Tromso

Registry information

Official study title

Parental Participation in Individually Customized Physiotherapy for Preterm Infants in the Neonatal Intensive Care Unit: Effects and Experiences. The Pragmatic Randomized Controlled Part.

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Mar 18, 2010
Registry last updated
Jan 6, 2023

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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