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: www.pactr.org
Trial no.: PACTR201902691230243 Date of Approval: 26/02/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of Milrinone Plus Sildenafil in the Treatment of Neonates with Persistent Pulmonary Hypertension
Official scientific title Efficacy of Milrinone Plus Sildenafil in the Treatment of Neonates with Persistent Pulmonary Hypertension
Brief summary describing the background and objectives of the trial Persistent pulmonary hypertension is a clinical syndrome characterized by suboptimal oxygenation as a result of sustained elevation in pulmonary vascular resistance after birth. In PPHN, there is vasoconstriction of the pulmonary vessels that may occur secondary to one of several reasons (e.g. prolonged hypoxemia, perinatal ischemic injury or an underlying lung parenchymal disease process). When the pulmonary vascular resistance exceeds the systemic vascular resistance, a right to left shunt of deoxygenated blood occurs through the persistent foramen ovale or the ductus arteriosus resulting in hypoxemia. The diagnosis of PPHN can be often difficult to make, especially in clinical setting in which pediatric echocardiography is not readily available. It should be considered basically in evaluating the cyanotic newborn. Oxygen saturation, chest radiograph, electrocardiography and echocardiography are all important in the diagnosis.There is a wide range of severity in pulmonary hypertension, a Doppler-estimated pulmonary artery systolic pressure of 40 mmHg has been assumed as a cutoff value for mild pulmonary hypertension. Severe pulmonary hypertension is diagnosed when pulmonary artery pressure exceeds two thirds the systemic blood pressure. Current guidelines states that lines of treatment for persistent pulmonary hypertension of the newborn include inhaled nitric oxide (INO) along with high frequency ventilation, surfactant and supportive measures including sedation and blood pressure support remain the mainstays in PPHN management. Extracorporeal membrane oxygenation (is an option when these measures fail. Oral/IV sildenafil, IV milrinone and inhaled prostaglandin inhibitors 2 (PGI2) may have a synergistic effect with INO and are being used more frequently. The aim of this work is to compare the efficacy of combined IV milrinone plus oral seldinafil to IV milrinone alone or oral sildenafil alone in the management of neonatal persistent pulmonary hypertension.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/04/2018
Actual trial start date 15/04/2018
Anticipated date of last follow up 15/04/2019
Actual Last follow-up date 15/04/2019
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Sildenafil 2mg/kg/dose/6hrs 14days Oral administration 20
Experimental Group Milrinone 0.5mcg/kg/min 14days Continuous Intravenous infusion 20
Control Group Sildenafil plus milrinone 2mg/kg/dose/6hrs + 0.5mcg/kg/min 14days Oral administration + Continuous Intravenous infusion 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All newborn cases diagnosed with persistent pulmonary hypertension of the newborn by echocardiography that had been admitted in neonatal intensive care unit of Alexandria University Children's Hospital. Neonates with any congenital heart disease. Neonates with congenital diaphragmatic hernia. Neonates with major surgical interventions. Neonates with congenital lung anomalies. 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 12/04/2018 IRB Faculty of Medicine Alexandria University
Ethics Committee Address
Street address City Postal code Country
17 Champollion Street El Messalah Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Improvement of pulmonary artery systolic pressure (PASP) by echo After 24 hours of treatment
Secondary Outcome Clinical improvement and fate During and till end of the management course
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria University Childrens Hospital Port-said street Elshatby Qesm Bab Sharqi Alexandria 21526 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed Gamal Mohamed Ghanem Portsaid street Elshatby Qesm Bab Sharqi Alexandria 21526 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Pediatrics Faculty of Medicine University of Alexandria Portsaid street Elshatby Qesm Bab Sharqi Alexandria 21526 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mamdouh Abdelgalil Elghandour ElShatby University Hospital for Chilren 12 PortSaid Street ElShatby Alexandria 21526 Egypt
Bahaa Salah Hammad ElShatby University Hospital for Chilren 12 PortSaid Street ElShatby Alexandria 21526 Egypt
Manal Abdel Malik Antonios ElShatby University Hospital for Chilren 12 PortSaid Street ElShatby Alexandria 21526 Egypt
Mohamed Gamal Mohamed Ghanem ElShatby University Hospital for Chilren 12 PortSaid Street ElShatby Alexandria 21526 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mamdouh Elghandour amrgada94@yahoo.com 00201223327316 Shatby University Hospital for Children 12 PortSaid Street ElShatby Qesm Bab Sharqi
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Professor of Pediatrics Faculty of Medicine University of Alexandria Egypt
Role Name Email Phone Street address
Scientific Enquiries Manal Abdel Malik malakmanal@yahoo.com 00201229733422 Shatby University Hospital for Children 12 PortSaid Street ElShatby Qesm Bab Sharqi
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Lecturer in Pediatrics Faculty of Medicine University of Alexandria Egypt
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 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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
Section Name Field Name Date Reason Old Value Updated Value
Reporting Plan to share IPD 25/02/2019 changed to No as WHO requested that Undecided be removed from the list Undecided No