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NCT03339037: TBIPED
Hyperbaric Oxygen Therapy Effect on Post Concussion Syndrome in Children
NA trial testing Hyperbaric oxygen therapy in Hyperbaric Oxygen Therapy in 52 participants. Terminated before completion.
1 November 2021
Quick facts
| Lead sponsor | Assaf-Harofeh Medical Center |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 52 |
| Start date | 1 November 2017 |
| Primary completion | 1 November 2021 |
| Estimated completion | 20 May 2022 |
| Sites | 1 location across Israel |
Drugs / interventions tested
- Hyperbaric oxygen therapy — full drug profile →
- Normobaric air SHAM
Conditions studied
- Hyperbaric Oxygen Therapy — all drugs for Hyperbaric Oxygen Therapy →
- Traumatic Brain Injury — all drugs for Traumatic Brain Injury →
- Post-Concussion Syndrome — all drugs for Post-Concussion Syndrome →
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):
-
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
Verify or expand the search:
- PubMed search for NCT03339037
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Hyperbaric oxygen therapy
Trials testing the same drug.
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- NCT06619808 — Hyperbaric Oxygen Therapy for Metabolic Dysfunction-associated Steatotic Liver Diseases · NA · recruiting
- NCT05980195 — Cognitive Improvement After Carotid Stenting in Hyperbaric Oxygen Therapy Trial · NA · not yet recruiting
- NCT06954376 — Hyperbaric Oxygen Therapy as a Neuroprotective Intervention in Pediatric Acquired Brain Injury With Cognitive Disability · NA · completed
- NCT06954389 — Hyperbaric Oxygen Therapy as a Neuroprotective Modality in Pediatric Acquired Brain Injury With Motor Disability · NA · completed
Other recruiting trials for Hyperbaric Oxygen Therapy
Currently open trials in the same condition.
- NCT03144206 — Hyperbaric Oxygen Therapy for Soft Tissue Sarcoma Pilot Study · Phase 4 · active not recruiting
Other Assaf-Harofeh Medical Center trials
Trials by the same sponsor.
- NCT07334639 — Metabolic Changes Associated With Weight Gain After Treatment of Achalasia · not yet recruiting
- NCT07276334 — Same Day Discharge Vs. Hospitalization for Operative Fixation of Distal Radius Fractures · NA · enrolling by invitation
- NCT07231900 — Sodium Bicarbonate in Intra-dialytic Hypertension in Chronic Hemodialysis Patients · Phase 2, PHASE3 · not yet recruiting
- NCT07252180 — Comparing Two Different Methods of Ablation of Inlet Patches (APC vs RFA) · NA · active not recruiting
- NCT04664790 — Hyperbaric Oxygen Therapy Compared to Cognitive Training in FASD · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03339037 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assaf-Harofeh Medical Center
- Last refreshed: 3 July 2024
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing