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.: PACTR201802002923191 Date of Approval: 31/12/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title nutritional management of ventilated children
Official scientific title Evaluation of high fat enteral feeding protocol in mechanically ventilated children: single center study
Brief summary describing the background and objectives of the trial the trial is based on the principle of using nutritional therapy as a means of modulating carbon dioxide (CO2) production in ventilated patients through the use of low carbohydrate- high lipid diets. the objective is to test the efficacy of this dietary modification in reduction of prolonged ventilation and/ or ventilation dependency with their big financial and social burdens on the institution and caregivers. also possible role in reducing the the length of stay, morbidity and mortality. Improving the nutritional and ventilatory outcomes of the critically ill ventilated patients through a new feeding protocol is the main target
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics,Respiratory,Respiratory failure
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/01/2017
Actual trial start date 11/02/2017
Anticipated date of last follow up 31/12/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
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
Parallel: different groups receive different interventions at same time during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group High fat low carbohydrate diet fat= 50% of total calories for 7 days modifying fat and carbohydrate portions of total calories 25 Active-Treatment of Control Group
Control Group standard diet for 7 days normal macronutrient distribution 26 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
mechanically ventilated expected PICU stay of at least 7 days known to have metabolic error know to have endocrinal problem known to have fat malabsorption 1 Month(s) 12 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 21/12/2016 ethical committee of cairo university school of medicine
Ethics Committee Address
Street address City Postal code Country
kasr alainy street Cairo 00202 Egypt
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 21/12/2016 ethical committee of cairo university school of medicine
Ethics Committee Address
Street address City Postal code Country
kasr alainy street Cairo 00202 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome extubation at day 7 of recruitment
Primary Outcome length of PICU stay at discharge
Secondary Outcome anthropometry at discharge
Secondary Outcome prealbumin level at day 7
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
PICU-1 Cairo University children hospital Elsayeda Zeinab Cairo 00202 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funding Cairo 00202 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor myself same as before Cairo 00202 Egypt University
COLLABORATORS
Name Street address City Postal code Country
pediatric intensive care team Elsayeda Zeinab Cairo 00202 Egypt
Chemical pathology team Kasr alaini street Cairo 00202 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shrouk Moataz Abdallah shroukmoataz14@gmail.com 00201099221393 19 Cairo university staff members compound-Giza
City Postal code Country Position/Affiliation
Cairo 00202 Egypt assistant lecturer of pediatrics- Cairo university
Role Name Email Phone Street address
Public Enquiries Hanaa Ibrahim Rady hanaaarady@gmail.com 00201205551976 Cairo university children hospitals
City Postal code Country Position/Affiliation
Cairo 00202 Egypt assistant professor of pediatrics and pediatric critical care
Role Name Email Phone Street address
Scientific Enquiries Nehal Mohamed Elkoofy nehalmelkoofy@gmail.com 00201227611585 Cairo university children hospitals
City Postal code Country Position/Affiliation
Cairo 00202 Egypt professor of pediatrics, pediatric hepatology and nutrition
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