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.: PACTR202103718608810 Date of Registration: 23/03/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Hemodynamic changes and Cardiac Performance in Preterm Neonates with Hemodynamically significant Patent Ductus Arteriosus on High-frequency oscillatory ventilation and conventional ventilation before and after the closure
Official scientific title Hemodynamic changes and Cardiac Performance in Preterm Neonates with Hemodynamically significant Patent Ductus Arteriosus on High-frequency oscillatory ventilation and conventional ventilation before and after the closure
Brief summary describing the background and objectives of the trial Patent ductus arteriosus (PDA) is a common congenital heart disease in preterm neonates. Blood flow through a PDA from the aorta into the pulmonary arteries leading to excessive flow through the pulmonary circulation and potential hypoperfusion of the systemic circulation. The hemodynamic physiologic consequences of this "ductal steal" depend upon the size of the shunt and the response of the heart, lungs, and other organs to the shunt. High-frequency oscillatory ventilation (HFOV) has been used to improve gas exchange in neonates who cannot be adequately ventilated by conventional means. However, its hemodynamic effects on Preterm Neonates with Hemodynamically significant PDA (hs-PDA) have not studied before. So. this study will aim to assess the hemodynamic effect of HFOV in preterm neonates with hs-PDA .
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: Devices
Anticipated trial start date 01/04/2021
Actual trial start date
Anticipated date of last follow up 31/12/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group high frequency oscillatory ventillation HFOV the preterm neonates will be put on HFOV until the preterm recovered and no more needs the ventilation. Every studied newborn will be subjected to full history taking and full clinical examination. Echocardiographic examinations, as well as cardiometry and cerebral ultrasound examination, will be performed before, 24 h, and 1 week after the use of HFOV. 30
Control Group convention ventilator the preterm neonates will be put on a conventional ventilator until the preterm recovered and no more needs the ventilation. All neonates will be subjected to full history taking and thorough clinical examination. Echocardiography, as well as cardiometry and cerebral ultrasound examination, will be performed before, 24 h, and 1 weak after the use of a conventional ventilator. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Preterm neonates <35 weeks’ gestational age (GA) with hs-PDAwho need mechanical ventilation.  Major congenital anomalies.  Neonates with dysrhythmias.  Neonates with chest deformities.  Maternal diabetes.  Infants with congenital heart disease other than a patent foreman ovale or small atrial septal defect.  Neonatal sepsis cases.  Hydrops fetalis.  Sever intraventricular hemorrhage. New born: 0 Day-1 Month 1 Day(s) 28 Day(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 26/11/2020 Local ethical committee of faculty of medicine of tanta uinversity
Ethics Committee Address
Street address City Postal code Country
Elgiesh street Tanta 31511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome left ventricular output before, 24 h, and 1 week after the intervention
Secondary Outcome right ventricular output, pulmonary pressure, left ventricular dimension and function, and intraventricular hemorrhage before, 24 h, and 1 week after the intervention
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 31511 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
Doaa El Amrousy elmotasem street Tanta 32712 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Doaa El Amrousy doaamoha@yahoo.com +0201289022229 elmotasem street
City Postal code Country Position/Affiliation
Tanta 32711 Egypt Associate professor of pediatrics
Role Name Email Phone Street address
Public Enquiries Mohamed Elkashlan dr.mohammed.eid1@gmail.com +201024645496 eleman street
City Postal code Country Position/Affiliation
Tanta 32711 Egypt Associate lecturer of pediatrics
Role Name Email Phone Street address
Scientific Enquiries Abdelrahman Elmashad armashad@yahoo.com +201206375111 elrakhaa street
City Postal code Country Position/Affiliation
Tanta 32711 Egypt Professor and head of pediatric department faculty of medicine tanta university
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