Valproic Acid in Treating Cyanotic Breath Holding Spells

Overview

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 self-limited by school age (4-5 years old) (90%). Classically, BHS were classified as cyanotic (blue), pallid (pale) and mixed based on the color change of the child during the spell. In general, cyanotic spells have been classically described in a toddler with excessive temper tantrums [stubborn, easily frustration or annoyed. The mechanisms of BHS are controversial. The most suggested cause of BHS is instability of the autonomic nervous system, inhibition of respiratory effort and cyanosis in cyanotic BHS and bradycardia or a brief asystole and cerebral hypoperfusion in pallid BHS. Iron deficiency anemia (IDA) has been widely regarded as a risk factor for BHS in nearly 50% of children due to reduced brain oxygenation [4]. It is generally agreed that the long-term prognosis is considered good [1]. There is no definite therapy for BHS. In children with low frequency spells, parental reassurance are just enough; however, high frequency spells may result in anxiety to the parents or fear from sudden death of the child or development of mental subnormality. Treatment of iron has been reported to result in reduction of the frequency of spells or its stoppage. Some reported improvement of BHS with piracetam [a nootropic drug known to increase brain oxygenation]. We did not find systematized published reports evaluating the effectiveness of antiepileptic drugs (AEDs) in reduction of spells frequency of cyanotic BHS or their stoppage.

Full Title of Study: “The Effectiveness of Valproic Acid in Treating Frequent Cyanotic Breath Holding Spells”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 30, 2018

Interventions

  • Drug: Valproic Acid
    • Treatment of children with frequent cyanotic breath holding spells (at least 4 spells per week) with 5 mg/kg/day for 6 months.

Arms, Groups and Cohorts

  • Other: cyanotic breath holding spells
    • drug, valproic acid: 5mg/kg/d for 6 months

Clinical Trial Outcome Measures

Primary Measures

  • frequency of spells after starting treatment with valproic acid
    • Time Frame: 6 months
    • The parents or legal guardians are the sources of information about the frequency of spells.

Participating in This Clinical Trial

Inclusion criteria : 1. Children with high frequency spells (≥ 4/week) of CBHS. 2. Children with parents who were wishing to provide treatment to their children. 3. 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. 4. Follow-up for 6 months after starting treatment with valproic acid. Exclusion criteria:

1. Primary neurologic disease, history of epilepsy or febrile convulsions, abnormal neurological examination and abnormal EEG. 2. Primary cardiac disease or presence of long QT syndrome in the ECG. 3. Presence of a hematologic (other than IDA) or other medical disease, electrolyte disturbance, hypoglycemia, hypocalcemia, impaired kidney or liver function tests. 4. Those with a doubtful diagnosis.

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 5 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assiut University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sherifa Ahmed Hamed, Professor of Neurology – Assiut University
  • Overall Official(s)
    • Sherifa A Hamed, M.D., Principal Investigator, Assiut University, Faculty of Medicine

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.