Infants with a single congenital malformation such as hypospadias or cryptorchidism, scheduled for surgery at 12 months of age Surgery Infants with a single congenital malformation such as hypospadias or cryptorchidism, scheduled for surgery at 12 months of age
Conditions
Interventions
Participants will be recruited from infants already recruited to the Basic Child Project. The Basic Child Project assesses 25 cognitive and trait constructs in 120 infants longitudinally from 6 to 30
Sponsors
Uppsala University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Single urological congenital malformation such as hypospadias or cryptorchidism 2. Scheduled for surgery at 12 months of age 3. =10 months old at time of recruitment 4. Informed consent obtained from parent or legal guardian
Exclusion criteria
Exclusion criteria: 1. Syndrome with known neurocognitive function impairment 2. Previous anesthetic exposure 3. Cyanotic heart disease 4. Born before 36 weeks of gestation 5. Cancer 6. A condition that affects the brain such as epilepsy or hydrocephalus 7. Neurosurgical surgery planned 8. Other surgery planned or performed during the study period 9. Parents that do not speak Swedish 10. Parents that have other problems with participation such as functional variation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any pattern of changes in the tests included in the Basic Child Project measured at 10 months and 18 months of age in the intervention group compared to changes over the same timespan in the unexposed control group. Baseline measurements take place at 10 months of age, the intervention takes place at 12 months of age and follow-up takes place 6 months later at 18 months of age. 1. Perceptual development is assessed through visual form perception, approximate number system, visual search and pupillary light response at baseline and 6 months 2. Learning capacity is assessed through visual sequencing, associative learning and probability assessment at baseline and 6 months 3. Social behaviour is evaluated through action prediction, action evaluation and gaze following at baseline and 6 months 4. Neurocognitive function and neurodevelopmental level is assessed via eye tracking (cognition: mathematics, physics, probabilities, contingency learning, geometry; social cognition: action prediction, social evaluation, gaze following, biological motion, face perception; attention; motor; pupillary light response, saccade latencies), play scenarios (motor: dynamic reaching, motor development; executive control: inhibition, set-shifting, working memory, pro-sociality/empathy, personality) or during interaction between parents and the child (responsiveness/sensitivity, attachment) at baseline and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Language skills measured by the Communicative Development Inventories (CDI) questionnaire at baseline and 6 months 2. Functional development measured by the functional evaluation questionnaire Vineland-II at baseline and 6 months 3. Adverse events during anesthesia documented at 6 months 4. Abnormal physiological or care-related events, according to the SAFETOTS 10 N matrix (www.safetots.org) documented at 6 months | — |
Countries
Sweden
Contacts
Public ContactPeter Frykholm
Outcome results
None listed