Paediatric anaesthesia & critical care
Long-term outcomes of early exposure to repeated general anaesthesia in children with cystic fibrosis (CF-GAIN): a multicentre, open-label, randomised controlled phase 4 trial
Primary resultResult — go to the resultDifference −1.7 95% CI −5.2 to 1.7Authors' conclusion
Our findings suggest that repeated general anaesthesia exposure in young children with cystic fibrosis is not related to functional impairment in attention, intellectual quotient, executive function, or brain structure compared with a group with fewer and shorter cumulative anaesthesia durations.
Study context
- Population
- Children with cystic fibrosis randomised in infancy in the Australasian Cystic Fibrosis Bronchoalveolar Lavage (ACFBAL) trial, assessed at mean age 12.8 years, 3 hospitals in Australia and 1 in New Zealand
- Participants
- 52 vs 45
- Comparison
- Bronchoalveolar-lavage (BAL)-directed therapy vs Standard care
- BAL-directed therapyn = 52
- Standard caren = 45reference
- Primary endpoint
- Composite score on Conners Continuous Performance test, second edition (attention, processing speed, response inhibition)
Methodological detailsphase 4, open-label, multicentre
- Phase 4
- Open-label
- Multicentre
Primary result
As reported in the abstract
Difference
−1.7
95% CI −5.2 to 1.7
P = 0.32
By group
BAL-directed therapy
51
mean · SD 8.1
Standard care
53
mean · SD 8.8
Secondary outcomes
Number of GA exposures · 2 years
Number of GA exposures · completion of ACFBAL trial
Number of GA exposures · CF-GAIN completion
Cumulative GA exposure time (complete data only) · end of ACFBAL trial · not prospectively collected
Other neurobehavioural measures (executive function, IQ scores) and brain imaging
- Similar performance in the two groups
Original publication
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