Status:
COMPLETED
Valproic Acid in Treating Cyanotic Breath Holding Spells
Lead Sponsor:
Assiut University
Conditions:
Breathhold
Eligibility:
All Genders
6-5 years
Phase:
PHASE1
Brief Summary
Breath holding spells (BHS) are common non-epileptic paroxysmal behavioral involuntary episodes occurring in up to 5.9% of healthy children. The attacks occur in early childhood (0.5-3 years) but are ...
Eligibility Criteria
Inclusion
- Inclusion criteria :
- Children with high frequency spells (≥ 4/week) of CBHS.
- Children with parents who were wishing to provide treatment to their children.
- Failure of alternatives modalities of treatment (e.g. iron supplements, piracetam, non-specific vitamins, etc) (tried for ≥ 3 months) to reduce the frequency of spells or stop them.
- Follow-up for 6 months after starting treatment with valproic acid.
- Exclusion criteria:
- Primary neurologic disease, history of epilepsy or febrile convulsions, abnormal neurological examination and abnormal EEG.
- Primary cardiac disease or presence of long QT syndrome in the ECG.
- Presence of a hematologic (other than IDA) or other medical disease, electrolyte disturbance, hypoglycemia, hypocalcemia, impaired kidney or liver function tests.
- Those with a doubtful diagnosis.
Exclusion
Key Trial Info
Start Date :
January 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2018
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04482764
Start Date
January 30 2017
End Date
December 30 2018
Last Update
July 23 2020
Active Locations (1)
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1
Assiut University Hospitals, Faculty of Medicine
Asyut, Egypt, 71516