Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201907632829653 Date of Approval: 10/07/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Heart rate variability in children with breath holding spells and the role of iron
Official scientific title Heart rate variability in children with breath holding spells and the role of iron
Brief summary describing the background and objectives of the trial Breath holding spells (BHS) are an involuntary paroxysmal clinical phenomenon observed in early childhood, resulting in serious parental anxiety. BHS are classified into two types; cyanotic spells and pallid spells]. In some cases, there are features of both cyanotic and pallid spells and these are termed mixed episodes. Autonomic nervous system dysfunction is thought to be the primary abnormality in the pathophysiology of BHS. This autonomic dysregulation can be detected by several methods including heart rate variability (HRV). Iron deficiency appears to be a contributing factor to BHS. Iron deficiency may have an impact on autonomic dysregulation in patients with BHS. Numerous reports have stressed the relationship between iron deficiency and BHS, demonstrated increased frequency of iron deficiency in children with BHS and also showed that iron supplementation resulted in a decrease of BHS frequency. we will study HRV before and after iron therapy in children with BHS.Moreover, we will study the effect of iron supplementation on the frequency and duration of BHS and the effect of serum iron level in these responses.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/08/2019
Actual trial start date
Anticipated date of last follow up 31/07/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Oral iron therapy 6 mg/kg/ day 3 months All included patients will recieve oral iron therapy in a dose of 6 mg/kg/day for 3 months 50
Control Group none none none no treatment will be given for the control group 50 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
infants and children with BHS not associated with any neurological or cardiological problems. children with congenital or acquired heart disease, children with any neurological illness, drug intake, and positive family history of neurological illness, or cardiac problems. Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 6 Month(s) 6 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 31/12/2018 local ethical committee of faculty of medicine of tanta uinversity
Ethics Committee Address
Street address City Postal code Country
elgeish street Tanta 31511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome evaluation of heart rate variability in children with breath holding spells before and after treatment with iron. before and after completion of treatment
Secondary Outcome duration and frequency of BHS before and after treatment. before and after completion of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
tanta University hospital Elgeish street tanta 31511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Doaa El Amrousy Elmotasem street Tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine of tanta university elgeish street tanta 31511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hala Agha madinet nasr cairo 33416 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Doaa El Amrousy doaamoha@yahoo.com 00201278155283 Elmotasem street
City Postal code Country Position/Affiliation
Tanta 32711 Egypt assistant professor of pediatrics
Role Name Email Phone Street address
Scientific Enquiries Hala Agha halaazza@gmail.com 00201001113284 madinet nasr
City Postal code Country Position/Affiliation
Cairo Egypt Professor of pediatrics
Role Name Email Phone Street address
Public Enquiries Mohamed Elkashlan mohamedkashlan@yahoo.com 00201222337746 Elmotasem street
City Postal code Country Position/Affiliation
Tanta Egypt assistant professor of anaesthesiology
Role Name Email Phone Street address
Principal Investigator Hala Agha halaazza@gmail.com 00201001113284 madinet nasr
City Postal code Country Position/Affiliation
Cairo Egypt Professor of pediatrics
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes study protocol and statistical analysis plan will be shared in a word document format Statistical Analysis Plan,Study Protocol 2 years controlled
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information