Forskning
Udskriv Udskriv
Switch language
Region Hovedstaden - en del af Københavns Universitetshospital
Udgivet

COpenhagen Neuroplastic TRaining Against Contractures in Toddlers (CONTRACT): protocol of an open-label randomised clinical trial with blinded assessment for prevention of contractures in infants with high risk of cerebral palsy

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

DOI

  1. How to safeguard the brain of extremely preterm infants?

    Publikation: Bidrag til tidsskriftKommentar/debatForskningpeer review

  2. Central data monitoring in the multicentre randomised SafeBoosC-III trial - a pragmatic approach

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. The effect of early probiotic exposure on the preterm infant gut microbiome development

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  4. Extremely Preterm Infant Admissions Within the SafeBoosC-III Consortium During the COVID-19 Lockdown

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  5. Safety of High-Volume Plasmapheresis in Children With Acute Liver Failure

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Vis graf over relationer

INTRODUCTION: Contractures are frequent causes of reduced mobility in children with cerebral palsy (CP) already at the age of 2-3 years. Reduced muscle use and muscle growth have been suggested as key factors in the development of contractures, suggesting that effective early prevention may have to involve stimuli that can facilitate muscle growth before the age of 1 year. The present study protocol was developed to assess the effectiveness of an early multicomponent intervention, CONTRACT, involving family-oriented and supervised home-based training, diet and electrical muscle stimulation directed at facilitating muscle growth and thus reduce the risk of contractures in children at high risk of CP compared with standard care.

METHODS AND ANALYSIS: A two-group, parallel, open-label randomised clinical trial with blinded assessment (n=50) will be conducted. Infants diagnosed with CP or designated at high risk of CP based on abnormal neuroimaging or absent fidgety movement determined as part of General Movement Assessment, age 9-17 weeks corrected age (CA) will be recruited. A balanced 1:1 randomisation will be made by a computer. The intervention will last for 6 months aiming to support parents in providing daily individualised, goal-directed activities and primarily in lower legs that may stimulate their child to move more and increase muscle growth. Guidance and education of the parents regarding the nutritional benefits of docosahexaenic acid (DHA) and vitamin D for the developing brain and muscle growth will be provided. Infants will receive DHA drops as nutritional supplements and neuromuscular stimulation to facilitate muscle growth. The control group will receive standard care as offered by their local hospital or community. Outcome measures will be taken at 9, 12, 18, 24, 36 and 48 months CA. Primary and secondary outcome measure will be lower leg muscle volume and stiffness of the triceps surae musculotendinous unit together with infant motor profile, respectively.

ETHICS AND DISSEMINATION: Full approval from the local ethics committee, Danish Committee System on Health Research Ethics, Region H (H-19041562). Experimental procedures conform with the Declaration of Helsinki.

TRIAL REGISTRATION NUMBER: NCT04250454.

EXPECTED RECRUITMENT PERIOD: 1 January 2021-1 January 2025.

OriginalsprogEngelsk
Artikelnummere044674
TidsskriftBMJ Open
Vol/bind11
Udgave nummer7
Sider (fra-til)e044674
ISSN2044-6055
DOI
StatusUdgivet - 6 jul. 2021

Bibliografisk note

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

ID: 68903550