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.: PACTR201801002768310 Date of Approval: 14/11/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Clinical - audit in Nutritional management in children with congenital heart diseases in Assiut University Children Hospital
Official scientific title Clinical audit in Nutritional management in children with congenital heart diseases in Assiut University Children Hospital
Brief summary describing the background and objectives of the trial Congenital heart diseases are structural abnormalities of the heart and great vessels present at birth that have or will have functional response at some point of life. Infant with isolated cardiac defects are generally born with a normal birth weight but develop nutritional and growth difficulties. Malnutrition remains prevalent in infants and children with congenital heart diseases.When oral intake is inadequate to meet growth requirements,nutrition support is an essential intervention.Energy intake and utilization are key factors affecting nutritional status and subsequently can influence surgical and developmental outcome, morbidity and mortality.So the aim of the study is to Assess the degree of adherence of medical stuff to the nutritional guidelines for patients with congenital heart diseases by assessing the nutritional status of the patients and compare them to the chosen standards and detect points that need to be improved and reassess the patients after implementation of changes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology,Circulatory System,malnutrition in children with congenital heart diseases,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/03/2017
Actual trial start date 01/03/2017
Anticipated date of last follow up 01/03/2018
Actual Last follow-up date 01/03/2018
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
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
Crossover: all participants receive all interventions in different sequence during study Randomised Stratified allocation by age and weight Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
Crossover: all participants receive all interventions in different sequence during study Randomised Stratified allocation by age and weight Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Dietary intake history according to age and weight follow up after 4 weeks Improvement of dietary intake 50
Experimental Group Anthropometric measure according to age and weight follow up after 4 weeks Improvement of dietary intake and add supplements 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All children with congenital heart diseases who attended and admitted at the cardiology unit and cardiology clinic Children with other diseases than congenital heart diseases Patients with multi system affection 1 Month(s) 16 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 01/03/2017 Ethical committee in Faculty of Medicine, Assiut University
Ethics Committee Address
Street address City Postal code Country
Faculty of medicine Assiut University Assiut Egypt Assiut 71526 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Assess the degree of adherence of medical stuff to the nutritional guidelines for patients with congenital heart diseases by assessing the nutritional status of patients and compare them to the chosen standards and detect points that need to be improved and reassess the patient after implementation of changes At the end of the study
Secondary Outcome Searching for defects,obstacles or needs to improve health services At the end of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of medicine Assiut University Egypt Faculty of medicine Assiut University Assiut Egypt Assiut 71526 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine Assiut University Faculty of medicine Assiut University Assiut Egypt Assiut 71526 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Assiut University Faculty of medicine Assiut University Assiut Egypt Assiut 71526 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Faculty of Medicine Assiut University Faculty of medicine Assiut University Assiut Egypt Assiut 71526 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Lamiaa Hussien lamiahaussien@gmail.com 01096824786 Assiut
City Postal code Country Position/Affiliation
Assiut 71526 Egypt
Role Name Email Phone Street address
Public Enquiries Nagwa Ali nammaali2015@aun.edu.eg 01096260950 Faculty of medicine Assiut University Assiut Egypt
City Postal code Country Position/Affiliation
Assiut 71526 Egypt
Role Name Email Phone Street address
Scientific Enquiries Osama Mahmoud asheer1970@aun.edu.eg 01001348864 Faculty of medicine Assiut University Assiut Egypt
City Postal code Country Position/Affiliation
Assiut 71526 Egypt
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information