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Completed

NCT Number: NCT04482764

Valproic Acid in Treating Cyanotic Breath Holding Spells

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.

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Key information

Age range

6 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Assiut University Hospitals, Faculty of Medicine

Asyut, 71516, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Valproic acid

Drug

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

Other names: sodium valproate

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

The Effectiveness of Valproic Acid in Treating Frequent Cyanotic Breath Holding Spells

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 23, 2020
Registry last updated
Jul 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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