Packard
Hyperbaric oxygenation improved parental reported disability inventory
Clinical bottom line:
| 1. No reliable evidence of benefit from HBOT 2. Unblinded parental scores for disability were said to be improved by HBOT 3. High incidence of middle ear barotrauma in children and parents |
Citation/s: Packard M. The Cornell Study. [[1]]
Lead author's name and fax: Maureen Packard (no contacts given)
Three-part Clinical Question: In moderate to severe cerebral palsy children (1 to 5 years), does HBOT improve neuro/psycho/motor function?
Search Terms: hyperbaric oxygen therapy, cerebral palsy, paediatric
The Study:Non-blinded randomised controlled trial without intention-to-treat.
The Study Patients: Developmentally delayed by >33% in one area neurocognitive or motor skill assessment, and who have not had seizures in the last 6 months. Average age at commencement of study 30 months, average motor age 7.5 months, average cognitive age and language age 12 months.
Control group (N = 14; 11 analysed): Nil specific (received delayed HBOT at 6 months after experimental group).
Experimental group (N = 12; 9 analysed): 40 one hour sessions HBOT at 1.5 ATA over 8 weeks
The Evidence:
Outcome |
Time to Outcome |
Overall patients |
Overall parents |
Difference |
|
|
Middle ear barotrauma requiring intervention |
any time |
45% |
35% |
? |
|
|
Improved parental disability inventory (PEDI) |
8 weeks |
P<0.05 |
In the whole study, 9 of 20 children compressed (45%) required myringotomy or ventilation tubes for middle ear barotrauma, while 7 parents also required this intervention. We have assumed one parent compressed for each child.
Comments:
1. A non-blinded study where the only reported significant differences were of parental assessment.
2. Small study with low power to detect important clinical differences.
3. Results poorly reported and usually for whole study rather than between group comparison.
4. No peer review and internet publication only.
5. No account of the fate of dropouts.
Appraised by: Shamani Singham Prince of Wales Hospital, Sydney ; Thursday, 18 November 2004Email: [singhams@sesahs.nsw.gov.au]
Kill or Update By: November 2015
