M.bennett at 02:14, 25 September 2021

2021-09-25T02:14:19Z

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2021-09-25T02:06:38Z

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'''No evidence of any benefit from a course of hyperbaric oxygen for children with spastic cerebral palsy.'''

'''Clinical Bottom Line:'''

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'''1. Hyperbaric oxygen did not improve gross motor function measures compared to a sham treatment. 2. The Paediatric Evaluation of Disability scores improved in both groups, but was not clinically important.'''

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'''Citation/s:'''1. Lacey DJ, Stolfi A, Pilati LE. Effects of hyperbaric oxygen on motor function in children with cerebral palsy. Annals of neurology. 2012 Nov 1;72(5):695-703 '''Lead author's name and fax: '''Daniel Lacey: laceyd@childrensdayton.org

'''Three-part Clinical Question:'''For children with spastic cerebral palsy, does the addition of a course of hyperbaric oxygen to standard therapy result in any improvement in gross motor function? '''Search Terms:''' Cerebral Palsy; motor function; paediatrics

'''The Study:'''Double-blinded concealed randomised controlled trial with intention-to-treat. '''The Study Patients:''' Children aged 3 to 8 years with spastic cerebral palsy '''Control group''' (N = 24; 22 analysed): 14% oxygen breathing at 1.5 ATA for 80 minutes daily, Monday to Friday to a total of 40 sessions over 8 weeks. '''Experimental group''' (N = 25; 24 analysed): As above but breathing 100% oxygen.

'''The Evidence:'''

 

{| class="Table" style="border:solid windowtext 1.0pt"
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| rowspan="2" style="width:167.6pt; border:solid windowtext 1.0pt" width="223" | '''Measure'''
| colspan="2" style="width:69.4pt; border:solid windowtext 1.0pt" width="93" | '''Sham Group'''
| colspan="2" style="width:69.35pt; border:solid windowtext 1.0pt" width="92" | '''HBO Group'''
| rowspan="2" style="width:55.2pt; border:solid windowtext 1.0pt" width="74" | '''Difference'''
| rowspan="2" style="width:80.25pt; border:solid windowtext 1.0pt" width="107" | '''95% CI'''
|-
| style="width:33.95pt; border:solid windowtext 1.0pt" width="45" | '''Mean'''
| style="width:33.95pt; border:solid windowtext 1.0pt" width="45" | '''SD'''
| style="width:33.95pt; border:solid windowtext 1.0pt" width="45" | '''Mean'''
| style="width:33.9pt; border:solid windowtext 1.0pt" width="45" | '''SD'''
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| style="width:167.6pt; border:solid windowtext 1.0pt" width="223" |
'''Gross Motor Function Measure-88 (end of treatment)'''

| style="width:33.95pt; border:solid windowtext 1.0pt" width="45" | 41.2
| style="width:33.95pt; border:solid windowtext 1.0pt" width="45" | 29.6
| style="width:33.95pt; border:solid windowtext 1.0pt" width="45" | 40.8
| style="width:33.9pt; border:solid windowtext 1.0pt" width="45" | 33.4
| style="width:55.2pt; border:solid windowtext 1.0pt" width="74" | -0.4
| style="width:80.25pt; border:solid windowtext 1.0pt" width="107" | -595 to 595
|-
| style="width:167.6pt; border:solid windowtext 1.0pt" width="223" |
'''Pediatric Evaluation of Disability -self care category (end of treatment)'''

| style="width:33.95pt; border:solid windowtext 1.0pt" width="45" | 49.5
| style="width:33.95pt; border:solid windowtext 1.0pt" width="45" | 15.2
| style="width:33.95pt; border:solid windowtext 1.0pt" width="45" | 52.1
| style="width:33.9pt; border:solid windowtext 1.0pt" width="45" | 20.5
| style="width:55.2pt; border:solid windowtext 1.0pt" width="74" | 2.6
| style="width:80.25pt; border:solid windowtext 1.0pt" width="107" | -199 to 194
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'''Comments:''' 1. 14% oxygen breathing at 1.5 ATA was to achieve the same PIO2 as breathing air at 1 ATA. 2. Sample size calculation suggested 42 patients in each group was required to find a 5% improvement in the HBO group versus the sham group. The trial was stopped early for futility on a planned interim analysis. Six month follow-up did not suggest a different outcome. 3. Patients randomised in permuted blocks of various sizes with allocation concealment and not likely subject to bias. 4. GMFM-88 has been validated in this group. PEDI scores improved statistically significantly but not to a clinically important extent in both groups, but did not differ between groups and this seemed to persist through to the six month follow-up on. Authors suggest this is a participation effect. 5. About one third of children experienced ear pain during the course of treatment and two required withdrawal of treatment (one in each group).

'''Appraised by:'''Mike Bennett POWH m.bennett@unsw.edu.au; Saturday, 25 September 2021 '''Kill or Update By:''' September 2026

Lacey - Revision history

M.bennett at 02:14, 25 September 2021

M.bennett: Created page with " '''No evidence of any be..."