Children aged under 3 years old and undergoing general anaesthesia and surgery for developmental dysplasia of the hip. Surgery
Conditions
Interventions
Current intervention as of 16/06/2023:
Participants that meet the eligibility criteria will be randomised to either the high or low oxygen exposure group. This will take place after their legal repre
Sponsors
University Hospital Southampton NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =6 months and =3 years at time of initial operation 2. Undergoing surgical management of DDH (unilateral or bilateral) 3. Completed informed consent form (ICF) from legal representative (LR (this is the person who is empowered to give informed consent on behalf of a participant. For most children this will be one or both parents. This may also be a guardian or custodian with legal custody)).
Exclusion criteria
Exclusion criteria: 1. Legal representative (LR) unable to provide completed ICF 2. Withdrawal of consent at any stage 3. Previous exposure to general anaesthesia at any stage of life, including in-utero (through maternal exposure at any stage until delivery) 4. Neurodevelopmental/neurodisability diagnosis (given or under investigation) from a paediatric service including autistic spectrum disorder (ASD), attention deficit disorder (ADHD), traumatic brain injury (TBI), down’s syndrome, cerebral palsy, epilepsy 5. Chronic respiratory diagnosis (given or under investigation) from a paedatric service, including bronchopulmonary dysplasia and cystic fibrosis with pulmonary manifestations, but excluding asthma 6. Clinical opinion that randomising the child’s oxygen exposure would be unsafe 7. Clinical opinion that the use of a volatile anaesthesic agent would be unsafe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This is a feasibility trial, with feasibility as the primary endpoint. This will comprise of several outcome measures as listed below measured at completion of the trial (target 10 patient recruitment): 1. Number of eligible patients screened – those meeting the eligibility criteria who were approached to take part 2. Recruitment rate – number of participants randomized divided by the number screened 3. Retention/withdrawal rate – number of participants that complete the study divided by the number who start it 4. Protocol compliance – number of deviations from trial protocol for each patient (and details) 5. Acceptability for participants and clinical staff – formal and informal feedback 6. Success of data management system - recorded issues with randomisation blinding and confidential storage. Opinion of research team on ease of use. 7. Additional resource requirements – List of time, costs and equipment not discussed in protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints will be 'epigenetic changes' which will be assessed by ‘DNA methylation’ at CpG sites present throughout the human genome through the use of the Illumina Infinium HumanMethylation 850K array. This will include both the level and location of change at at different time-points and between the two oxygen exposure groups. This will be evaluated once all samples for all recruited participants have been collected and undergone HumanMethylation 850K array analysis. | — |
Countries
England, United Kingdom
Outcome results
None listed