The Norwegian Physical Therapy Study in Preterm Infants

Sponsor

University Hospital of North Norway (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01089296

Collaborator

University of Tromso (Other), St. Olavs Hospital (Other), University of Illinois at Chicago (Other), Oslo University Hospital (Other)

150

Enrollment

Location

Arms

189.5

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Movement Disorders	Other: Individually customized physiotherapy	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (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.

Actual Study Start Date :

Mar 18, 2010

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Other: 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).

Arm

Intervention/Treatment

Other: 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).

Outcome Measures

Primary Outcome Measures

Peabody Developmental Motor Scales(PDMS-2) [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 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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Days to 10 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.