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.: PACTR202104624409011 Date of Approval: 06/04/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of hemodynamic status and cardiac performance in neonates with persistent pulmonary hypertension on high-frequency oscillatory ventilation versus conventional ventilation before and after treatment
Official scientific title Evaluation of hemodynamic status and cardiac performance in neonates with persistent pulmonary hypertension on high-frequency oscillatory ventilation versus conventional ventilation before and after treatment
Brief summary describing the background and objectives of the trial Persistent Pulmonary Hypertension of Newborn (PPHN) is a condition characterized by marked pulmonary hypertension resulting from elevated pulmonary vascular resistance (PVR) and altered pulmonary vaso-reactivity. Though PPHN is a less common cause of respiratory distress in newborns, it has a significant impact on morbidity and mortality. High-frequency ventilation (HFV) has been used with increasing frequency for PPHN.HFOV improves oxygenation at lower mean airway pressures and ventilation of infants with PPHN, as compared to conventional ventilation. However, there are few systematic studies about its hemodynamic effects. The aim of the study is to compare the hemodynamic status and cardiac performance in neonates with persistent pulmonary hypertension on HFOV versus the conventional mechanical ventilation before and after treatment.
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
 Neonates with persistent pulmonary hypertension  Neonates with major congenital anomalies.  Neonates with dysrhythmias.  Neonates with chest deformities.  Maternal diabetes.  Neonates with congenital heart disease except for small defects such as PDA or ASD.  Neonatal sepsis cases.  Evidence of perinatal asphyxia with Apgar score <5 at 5 minutes.  Neonates with hydrops fetalis.  All surgical cases.  Neonates with severe 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 right ventricular output before, 24 h, and 1 week after the intervention
Secondary Outcome left ventricular output, pulmonary pressure, right ventricular diameter, left ventricular dimension and function, intraventricular hemorrhage, and mortality 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 Hassan Koura hgkoura@gmail.com +0201002056905 elbendary street
City Postal code Country Position/Affiliation
Tanta 31511 Egypt assistant lecture of pediatrics
Role Name Email Phone Street address
Public Enquiries 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
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 the study protocol and statistical analysis plan will be shared in a word document format Statistical Analysis Plan,Study Protocol 2 years 2 years
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