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.: PACTR202207646279984 Date of Approval: 22/07/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Nasal High Frequency Oscillatory Ventilation versus Nasal Continuous Positive Airway Pressure as Initial Therapy in Respiratory Distress Syndrome in Preterm Newborns
Official scientific title Nasal High Frequency Oscillatory Ventilation versus Nasal Continuous Positive Airway Pressure as Initial Therapy in Respiratory Distress Syndrome in Preterm Newborns
Brief summary describing the background and objectives of the trial This study investigate the use of early nasal high-frequency oscillation ventilation compared to nasal continuous positive airway pressure may reduce the requirement for invasive respiratory assistance in respiratory distress syndrome preterm newborns.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Neonatal Diseases,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/05/2021
Actual trial start date 01/05/2021
Anticipated date of last follow up 01/06/2022
Actual Last follow-up date 01/06/2022
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 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
Control Group nasal continuous positive airway pressure 2 days nasal continuous positive airway pressure for preterms with RDS 30 Active-Treatment of Control Group
Experimental Group nasal high frequency ventilation 2 days nasal high frequency ventilation in preterm neonates 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Appropriate weight for the gestational age of preterm infants between 280/7 and 336/7 weeks of gestation was determined by the New Ballard Score (Ballard et al., 1991), data from the last menstrual period (LMP) or ultrasound measurement of the fetus. 2. Respiratory distress syndrome diagnosis was made on the basis of the combination of clinical features and radiological features. • Full-term neonates. • Other causes of respiratory distress than RDS. • Need for intubation for mechanical ventilation during neonatal resuscitation or on the first 2 days of life. • Major congenital malformations. • Intrauterine growth retardation. New born: 0 Day-1 Month 0 Day(s) 2 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 28/08/2019 ethical commitee of tanta unveristy faculty of medicine
Ethics Committee Address
Street address City Postal code Country
El-Gharbia Govenorate,Tanta . El-Gash st. Medical Campus The Faculty of Medicine tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome failure of technique and need of intubation 2 days
Secondary Outcome duration of noninvasive respiratory support, exposure to invasive ventilation, duration of respiratory support, hospital stay, and partial pressure of carbon dioxide clearance till weaning of oxygen support
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta university hospital elbahr street Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ghada Al ashkar manshia gadida tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta unversity hospital El-Gharbia Govenorate,Tanta . El-Gash st. Medical Campus The Faculty of Medicine tanta 31527 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ashraf Abohamama Elhelw street tanta Egypt
Hamid elsharkway elbahr street tanta Egypt
Ghada Alashkar manshia gedida tanta Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Hamid el sharkawy hamedelsharkawy@hotmail.com +201005106898 el bahr street
City Postal code Country Position/Affiliation
tanta Egypt professor of pediatrics tanta university
Role Name Email Phone Street address
Principal Investigator ghada al ashkar nazihdrghada@gmail.com +201066370079 manshia gadida
City Postal code Country Position/Affiliation
tanta Egypt specialist of pediatrics tanta university
Role Name Email Phone Street address
Scientific Enquiries ashraf abohamama ashraf.abohamama@med.tanta.edu.eg +201002060505 el helw street
City Postal code Country Position/Affiliation
tanta Egypt assistant professor of pediatric tanta university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Study Protocol 1 year Researchers who provide a methodologically sound proposal To achieve aims in the approved proposal Proposal should be directed to ashraf.abohamama@med.tanta.edu.eg. To gain access, data requestors will need to sign a data access agreement.
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