The Norwegian Physical Therapy Study in Preterm Infants

This study is currently recruiting participants.
Verified December 2013 by University Hospital of North Norway
Sponsor:
Collaborators:
University of Tromso
St. Olavs Hospital
University of Illinois at Chicago
Oslo University Hospital
Information provided by (Responsible Party):
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT01089296
First received: March 16, 2010
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Preterm Infants
Other: Individually customized physiotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Parental Participation in Individually Customized Physiotherapy for Preterm Infants in the Neonatal Intensive Care Unit: Effects and Experiences. The Pragmatic Randomized Controlled Part.

Resource links provided by NLM:


Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • Peabody Developmental Motor Scales(PDMS-2) [ Time Frame: Two years post term age ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
    Results from the different Time Frames will be published successively as the project proceeds.


Estimated Enrollment: 150
Study Start Date: March 2010
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Individually customized physiotherapy
The intervention involves handling the infant and changing its position. It focuses on improving symmetry, muscle balance and movement in infants. The parent who is with the infant during the admission period will carry out the daily intervention after being taught by the physiotherapist.
Other: Individually customized physiotherapy
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
No Intervention: Control
Ordinary follow up in the Neonatal Intensive Care Unit (NICU).

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 10 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01089296

Contacts
Contact: Gunn K. Øberg, PT/PhD +47 77 75 58 68 Gunn.Kristin.Oeberg@uit.no
Contact: Per I. Kaaresen, Dr. med/PhD Per.Ivar.Kaaresen@unn.no

Locations
Norway
University Hospital of North Norway Recruiting
Tromsø, Troms fylke, Norway, 9013
Contact: Gunn K. Øberg, PhD    +47 77 75 58 68    gunn.kristin.oberg@unn.no   
Principal Investigator: Gunn K. Øberg, PhD, PT         
Sub-Investigator: Per I. Kaaresen, PhD, Dr.med         
Sub-Investigator: Lone Jørgensen, Professor         
Sub-Investigator: Tordis Ustad, MSc, PT         
Sponsors and Collaborators
University Hospital of North Norway
University of Tromso
St. Olavs Hospital
University of Illinois at Chicago
Oslo University Hospital
Investigators
Principal Investigator: Gunn K. Øberg, PhD University of Tromsø / University Hospital of North Norway
  More Information

No publications provided by University Hospital of North Norway

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT01089296     History of Changes
Other Study ID Numbers: 1/370-00/09-A
Study First Received: March 16, 2010
Last Updated: December 17, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by University Hospital of North Norway:
Infants born preterm
Early physiotherapy intervention
Motor development
Parental participation
Parental competency

ClinicalTrials.gov processed this record on April 14, 2014