Does general anaesthesia and oxygen affect markers on DNA in children?

Phase 4

• Conditions: Children aged under 3 years old and undergoing general anaesthesia and surgery for developmental dysplasia of the hip.; Surgery

• Registration Number: ISRCTN58025172
• Lead Sponsor: niversity Hospital Southampton NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-22
• Last Update Posted: 3 October 2023
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 10

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified