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NCT03339037: TBIPED

Hyperbaric Oxygen Therapy Effect on Post Concussion Syndrome in Children

Terminated NA Last updated 3 July 2024
What this trial tests

NA trial testing Hyperbaric oxygen therapy in Hyperbaric Oxygen Therapy in 52 participants. Terminated before completion.

Timeline
1 November 2017
Primary endpoint
1 November 2021
20 May 2022

Quick facts

Lead sponsorAssaf-Harofeh Medical Center
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingquadruple
Primary purposetreatment
Enrollment52
Start date1 November 2017
Primary completion1 November 2021
Estimated completion20 May 2022
Sites1 location across Israel

Drugs / interventions tested

Conditions studied

Sponsor

Assaf-Harofeh Medical Center

Who can join

Adults 8 to 16, any sex, with Hyperbaric Oxygen Therapy or Traumatic Brain Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Due its high incidence, mTBI and its consequences of PPCS are a major public health issue. There is no consensus regarding the treatment of PPCS in pediatrics. Relying on its results in adults, HBOT offers a promising new direction of treatment, which targets the basic pathological processes responsible for post-concussion symptoms. The effect of hyperbaric oxygen therapy in pediatric TBI has never been evaluated. The aim of the current study is to evaluate in a prospective cross-over, randomized study, the effect of HBOT on children with PPCS due to mild TBI.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Hyperbaric oxygen therapy in children with post-concussion syndrome improves cognitive and behavioral function: a randomized controlled trial.
    Hadanny A, Catalogna M, Yaniv S, Stolar O, et al · · 2022 · cited 17× · PMID 36151105 · DOI 10.1038/s41598-022-19395-y

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Other trials of Hyperbaric oxygen therapy

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Other Assaf-Harofeh Medical Center trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03339037.

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