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.: PACTR201609001779105 Date of Approval: 12/09/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title High frequency oscillatory ventilation versus conventional ventilation in Pediatric Acute Respiratory distress syndrome: a randomized controlled study
Official scientific title High frequency oscillatory ventilation versus conventional ventilation in Pediatric Acute Respiratory distress syndrome: a randomized controlled study.
Brief summary describing the background and objectives of the trial Pediatric Acute Respiratory Distress Syndrome (PARDS) is a well known cause of mortality and morbidity among pediatric intensive care units (PICUs) and the comparative effect of high frequency oscillation (HFO) or conventional ventilation (CV) is still unclear on outcome. This randomized controlled study was performed to compare the efficacy of both modes in improving oxygenation and exploring their effects on outcome.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics,Pediatric Acute Respiratory Distress Syndrome,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/01/2011
Actual trial start date 01/01/2011
Anticipated date of last follow up 31/01/2016
Actual Last follow-up date 30/04/2016
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
Recruitment status Completed
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 Randomised Permuted block randomisation (block size was variable minimum of 4) Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Conventional ventilation Ventilation period The Two step process of ventilation weaning according to the international consensus. 100 Active-Treatment of Control Group
Experimental Group High frequency oscillation Ventilation period - Maintaining lung volume 8 ribs or more on plain chest X-ray and disappearance of white lung appearance. 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
If patients had a ratio of the partial pressure of arterial oxygen (Pao2) to the fraction of inspired oxygen (Fio2) of 200 mm Hg or less and bilateral pulmonary infiltrates were visible on chest radiography without evidence of left atrial hypertension, according to American¿European Consensus Conference Committee (AECC) definition of ARDS. - pulmonary edema of cardiac origin or due to volume overload - patients with congenital heart disease, - diagnosis of cardiomyopathy or myocarditis, - post cardiac surgery for congenital heart defects. 1 Month(s) 14 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 31/01/2011 Faculty of Medicine, Alexandria University IRB
Ethics Committee Address
Street address City Postal code Country
Chambillion st. Azarita, Alexandria 21526 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Oxygenation improvement 24 hours after entry study
Secondary Outcome 30 day mortality 30th day after study entry
Secondary Outcome PICU length of stay(survivors) At end of stay
Secondary Outcome Mechanical ventilation days (survivors) At successful extubation
Secondary Outcome Mechanical ventilation free days (survivors)till 30 days Ventilation free days among survivors
Secondary Outcome Air leaks occurrence Once occur
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria University PICU Port Saed Street Alexandria 21526 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Paediatric Department, Alexandria University Port Saed Street Alexandria 21526 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Paediatric Department, Alexandria University Port Saed Street Alexandria 21526 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Ahmed El-Nawawy ElShatby University Hospital, Port Saed Street Alexandria 21526 Egypt
Azza Ahmad AhmadMostafa ElShatby University Hospital, Port Saed Street Alexandria 21526 Egypt
Hassan Heshmat Hassan ElShatby University Hospital, Port Saed Street Alexandria 21526 Egypt
Ahmed Khalil Abouahmed ElShatby University Hospital, Port Saed Street Alexandria 21526 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed El-Nawawy Dr_anawawy@yahoo.com 002-035839168 Port-Saed Street, Shatby
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Professor of Pediatrics, Faculty of Medicine, University of Alexandria
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Azza Mustafa moustafaazza60@gmail.com 002-01002333413 Port-Saed Street, Shatby
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Professor of Pediatrics, Head of PICU, Faculty of Medicine, University of Alexandria
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information