Effect of early physiotherapy in children born preterm

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

Mrs Tordis Ustad
Public, Principal Investigator

IKOM, NTNU
Postboks 8900, Torgarden
Trondheim
7491
Norway

ORCID ID	0000-0001-9668-6905
Phone	+47 99095103
Email	tordis.ustad@ntnu.no

Mrs Kari Anne I. Evensen
Scientific

IKOM, NTNU
Postboks 8900, Torgarden
Trondheim
7491
Norway

ORCID ID	0000-0002-0129-0164
Phone	+47 97733635
Email	karianne.i.evensen@ntnu.no

Study information

Eligibility

Locations

Countries of recruitment

• Norway

Study participating centres

Sponsor information

Norwegian University of Science and Technology
University/education

Postboks 8900, Torgarden
Trondheim
7491
Norway

Phone	+47 73 59 50 00
Email	postmottak@ntnu.no
Website	https://www.ntnu.no
"ROR"	https://ror.org/05xg72x27

Funders

Funder type

Government

Results and Publications

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).