Clinical trial NCT01089296: The Norwegian Physical Therapy Study in Preterm Infants
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Movement Disorders
Keywords: Infants born preterm
Early physiotherapy intervention
Motor development
Parental participation
Parental competency
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: University of Tromso
name: St. Olavs Hospital
name: University of Illinois at Chicago
name: Oslo University Hospital
First posted: 2010-03-18
Enrollment: 153
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Peabody Developmental Motor Scales(PDMS-2)
timeFrame: Two years post term age
Secondary outcomes:
measure: 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)
timeFrame: 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.
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
state: Troms Fylke
Study officials:
affiliation: University of Tromsø / University Hospital of North Norway
name: Gunn K. Øberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oberg GK, Girolami GL, Campbell SK, Ustad T, Heuch I, Jacobsen BK, Kaaresen PI, Aulie VS, Jorgensen L. Effects of a Parent-Administered Exercise Program in the Neonatal Intensive Care Unit: Dose Does Matter-A Randomized Controlled Trial. Phys Ther. 2020 May 18;100(5):860-869. doi: 10.1093/ptj/pzaa014.
citation: Ustad T, Evensen KA, Campbell SK, Girolami GL, Helbostad J, Jorgensen L, Kaaresen PI, Oberg GK. Early Parent-Administered Physical Therapy for Preterm Infants: A Randomized Controlled Trial. Pediatrics. 2016 Aug;138(2):e20160271. doi: 10.1542/peds.2016-0271.
citation: Oberg GK, Campbell SK, Girolami GL, Ustad T, Jorgensen L, Kaaresen PI. Study protocol: an early intervention program to improve motor outcome in preterm infants: a randomized controlled trial and a qualitative study of physiotherapy performance and parental experiences. BMC Pediatr. 2012 Feb 15;12:15. doi: 10.1186/1471-2431-12-15.