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Study design
Design: Randomised controlled trial.
Allocation: Randomisation was done by university staff. Allocation was concealed using sealed envelopes that were sequentially numbered.
Blinding: All patients, care providers and investigators were blinded. Only hyperbaric oxygen (HBO) technicians were aware of group assignment.
Study question
Setting: Ambulatory HBO clinic in the USA.
Patients: Forty-nine children aged 3 to 8 years with spastic cerebral palsy (CP), with no previous HBO treatments, recent thoracic surgery, changes of spasticity medications or history of hypoxic-ischaemic encephalopathy.
Intervention: Children were randomised to receive either hyperbaric 100% oxygen (HBO) or hyperbaric air (HBA), at 1.5 atmospheres, for 60 min, once per weekday for a total of 40 treatments.
Outcomes: Primary outcome was a change in Gross Motor Function …
Correspondence to Dr Daniel J Lacey, Department of Neurology, Children's Medical Center of Dayton, One Children's Plaza, Dayton, OH 45404, USA; laceyd{at}childrensdayton.org