Effect of early physiotherapy in children born preterm
| ISRCTN | ISRCTN12148268 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12148268 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 2019/2833/SISO |
| Sponsor | Norwegian University of Science and Technology |
| Funder | Helse Midt-Norge |
- Submission date
- 13/12/2024
- Registration date
- 18/12/2024
- Last edited
- 19/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Every year, 3000 infants are born preterm in Norway, or 6% of all births. Thanks to modern medicine, 90% survive. Studies of previous generations of preterm children show a high risk of adverse outcomes, amongst other motor difficulties and reduced quality of life, which might persist to adult age. Early interventions are thought to be important to promote coping and participation. In 2010-14, a study was carried out in three university hospitals in Norway. Infants born before 32 weeks' gestation received either early physiotherapy or standard care. There was an immediate effect with better motor function in the intervention group, but at two years there was no difference between the groups. However, motor function may not be stable throughout childhood, and assessment at two years may be too early to determine long-term effects. This study will determine the effect of the intervention at 7-10 years and examine whether motor function has consequences for the child’s level of physical activity, mental health and quality of life. Data have already been collected. User representatives have contributed to the planning of the study, which ensures the relevance for preterm children and their families. The study complies with the strategic priorities of Central Norway Regional Health Authorities by involving multidisciplinary and clinically relevant patient-centered research. The aim of the study is to explore the long-term effect of early physiotherapy intervention and the interplay between motor function, physical activity, mental health and quality of life.
Who can participate?
Children aged from 7 to 10 years old, one group born preterm who have participated in a study of early intervention, and another group of children born at term.
What does the study involve?
Even though the quality of intensive care for infants born preterm has improved during the recent decades and the survival of the most immature infants has increased, many will still be suffering from long-term adverse outcomes. The study involves a clinical follow-up at 7-10 years of age with assessments of motor function, physical activity and quality of life in children born preterm and at term. The preterm-born children had previously been participants in a multicenter, randomized control study of early intervention. Data collection was carried out between May 2020 and September 2022
What are the possible benefits and risks of participating?
This study is expected to provide new knowledge beneficial to individuals born very preterm and their families as well as health and educational professionals. The results from the study might help clinicians decide whether to implement early physiotherapy for children born very preterm. During childhood, preterm birth has public health implications, related to paediatric healthcare resources, family support, and school education. The range of developmental difficulties for children born preterm is diverse, but they all may significantly affect the quality of life. Knowledge about associations between motor function, physical activity, mental health and quality of life has implications also for primary health care as well as school and educational systems. Moreover, the results can guide public health policy relevant to both community and specialised health care services. The study will provide important contributions to paediatric medicine, physiotherapy, occupational therapy, movement sciences, psychology and mental health disciplines for children and adolescents. Dissemination and implementation of results will contribute to identifying the multidisciplinary needs of preterm birth. The achievements will provide the basis for further follow-up research on preterm birth.
Participants are offered a thorough clinical examination, receive medically relevant feedback and are referred to appropriate health services if needed. All methods are non-invasive and entail a very low risk of injury or adverse events.
Where is the study run from?
The Norwegian University of Science and Technology and St Olavs Hospital
When is the study starting and how long is it expected to run for?
June 2018 to August 2022. Data collection started in May 2020.
Who is funding the study?
The study was supported by grants from The Central Norway Regional Health Authority (RHA - Helse Midt-Norge)
Who is the main contact?
Tordis Ustad (Project leader), tordis.ustad@ntnu.no
The main contact is Kari Anne I. Evensen, Professor at NTNU, karianne.i.evensen@ntnu.n
Contact information
Public, Principal investigator
IKOM, NTNU
Postboks 8900, Torgarden
Trondheim
7491
Norway
 ORCID ID |
0000-0001-9668-6905 |
|---|---|
| Phone | +47 99095103 |
| tordis.ustad@ntnu.no |
Scientific
IKOM, NTNU
Postboks 8900, Torgarden
Trondheim
7491
Norway
| ORCID ID |
0000-0002-0129-0164 |
|---|---|
| Phone | +47 97733635 |
| karianne.i.evensen@ntnu.no |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Long-term follow-up of a randomized controlled trial on effect of early physiotherapy for children born very preterm. |
| Secondary study design | Longitudinal study |
| Study type | Participant information sheet |
| Scientific title | Motor function, mental health, and quality of life in children born very preterm: A follow-up of a randomized controlled trial. |
| Study acronym | NOPPI 2 |
| Study objectives | Children born very preterm and exposed to intervention have slightly better motor function at 7-10 years old than children receiving standard care. Both preterm groups have poorer motor function, mental health, and quality of life, and are less physically active compared to a control group of children born at term. |
| Ethics approval(s) |
Approved 10/09/2019, The Regional Committee for Medical and Health Research Ethics North in Norway (REC North) (UiT Norges arktiske universitet, Postboks 6050 Langnes, Tromsø, 9037, Norway; +47 77645232; rek-nord@asp.uit.no), ref: 10013 |
| Health condition(s) or problem(s) studied | Health and well-being of children born very preterm at 7 -10 years of age. |
| Intervention | The study involves a clinical follow-up at 7-10 years of age with assessments of motor function, physical activity and quality of life in children born preterm and at term. The preterm-born children had previously been participants in a multicenter, randomized control study of early intervention. Data collection was carried out between May 2020 and September 2022 |
| Intervention type | Other |
| Primary outcome measure(s) |
Motor function is measured using the Movement Assessment Battery for Children – second edition (Movement ABC-2), the High-level Mobility Assessment Tool, the Grooved Pegboard Test and the Trail Making Test-5 at one timepoint |
| Key secondary outcome measure(s) |
1. Physical Activity measured using a Tri-axial accelerometer Axivity AX3 for a period of 7 days when the child was 7 to 10 years old |
| Completion date | 25/08/2022 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 10 Years |
| Sex | All |
| Target sample size at registration | 195 |
| Total final enrolment | 175 |
| Key inclusion criteria | 1. Children born between 24 and 32 weeks gestational age, in 2010 to 2014, having participated in a study of early intervention 2. Term born children |
| Key exclusion criteria | 1. Using walking aids 2. Not able to walk 20 meters independently |
| Date of first enrolment | 19/05/2020 |
| Date of final enrolment | 25/08/2022 |
Locations
Countries of recruitment
- Norway
Study participating centres
Trondheim
7030
Norway
Tromsø
9019
Norway
Oslo
0450
Norway
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are stored in a non-publicly available repository (https://data.tsd.usit.no) The datasets generated during and /or analysed during the current study will be available upon reasonable request from Kari Anne I. Evensen, karianne.i.evensen@ntnu.no |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/12/2024: Plain English summary updated.
17/12/2024: Study's existence confirmed by the Regional Committee for Medical and Health Research Ethics North in Norway (REC North).
