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.
|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.|
- 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.
- 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.
|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)|
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.
No Intervention: Control
Ordinary follow up in the Neonatal Intensive Care Unit (NICU).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01089296
|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|
|University Hospital of North Norway||Recruiting|
|Tromsø, Troms fylke, Norway, 9013|
|Contact: Gunn K. Øberg, PhD +47 77 75 58 68 firstname.lastname@example.org|
|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|
|Principal Investigator:||Gunn K. Øberg, PhD||University of Tromsø / University Hospital of North Norway|