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.: PACTR201707002434194 Date of Approval: 16/07/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Sustained lung inflation of preterms (SLIP)
Official scientific title Effect of the use of sustained lung inflation in the treatment of preterm infants with respiratory distress in the delivery room
Brief summary describing the background and objectives of the trial Respiratory distress syndrome (RDS), remains a major clinical problem among preterm infants. Outcome in RDS was ameliorated primarily by the introduction of pharmacologic acceleration of pulmonary maturity and the development of surfactant replacement therapy. The introduction of mechanical ventilation for the management of severe RDS changed the natural course of the disease, resulting in increased survival of smaller and sicker infants. The incidence of complications in the survivors of RDS remains signi¿cant. These complications could be either consequences of RDS, or side effects of its treatment, or sequelae of the prematurity itself. Also the occurrence of BPD has remained mostly unchanged. Sustained lung inflation (SLI) procedure in preterm infants for prevention of MV has been suggested aiming at acceleration of clearance of lung fluid and establishing adequate functional residual capacity to maintain normal gas exchange. The aim of this trial is to evaluate impact of applying the SLI maneuver in the delivery room to preterm infants born ¿ 33 weeks¿ gestation requiring respiratory support as regard the need for MV in the first 3 days of life and the outcome as regard death or development of BPD.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics,Respiratory,Respiratory distress in preterms
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/06/2015
Actual trial start date 01/08/2015
Anticipated date of last follow up 31/12/2015
Actual Last follow-up date 30/06/2016
Anticipated target sample size (number of participants) 126
Actual target sample size (number of participants) 145
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
Randomised Permuted block randomization (variable block size) Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization (variable block size) Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group SLIP Immediately after birth Sustained lung inflation after birth for 15s using PiP/PEEP of 25/5 and can be repeated for another 15s using PIP/PEEP of 30/6 71
Control Group Standard Immediately after birth Initial steps of resuscitation to be followed by positive pressure ventilation if needed according to the NRP guidelines 74 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Preterm babies ¿33 weeks gestation Major congenital anomalies Considered non viable by the attending neonatologist Fetal hydrops 0 Day(s) 0 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 01/06/2015 IRB, Ethics Committee, Faculty of Medicine, Alexandria University
Ethics Committee Address
Street address City Postal code Country
17 Champollion Street, El Messalah, Alexandria, Egypt Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Need for mechanical ventilation within the 1st 72 hours of life First 72 hours of life
Secondary Outcome Broncho-pulmonary dysplasia (need for supplemental oxygen at time points of assessment <32 weeks: 36 weeks¿ PMA or discharge home whichever comes first. ¿ 32weeks¿ >28 days but < 56 days postnatal age or discharge home whichever comes first
Secondary Outcome Death Any time during hospitalization but after day 3 of life
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
NICU of Alexandria University Maternity Hospital Port Said St., El Shatby, Beside Bibliotheca of Alexandria Alexandria 21526 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Pediatric Departement, Faculty of Medicine, Alexandria University Port Said St., El Shatby, Beside Bibliotheca of Alexandria Alexandria 21526 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Pediatric Departement, Faculty of Medicine, Alexandria University Port Said St., El Shatby, Beside Bibliotheca of Alexandria Alexandria 21526 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hesham Ghazal 680 ElHurreya road Louran Alexandria 21611 Egypt
Khalid M. Saad 41 Mostafa Kamel st. Smouha Alexandria 21615 Egypt
Hassan Heshmat 7 Nour ElDin st. Camp Shizar Alexandria 21525 Egypt
Marwa A. ElKarim 249 Gamal Abd ElNasser st. Miami Alexandria 21411 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hesham Ghazal heshamgz@yahoo.com 00201227401491 680 ElHurreya road Louran
City Postal code Country Position/Affiliation
Alexandria 21611 Egypt Head of NICU, Faculty of Medicine, Alexandria University
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 002-01223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Marwa ElKarim marwaabdelkarem@gmail.com 00201004008910 249 Gamal Abd ElNasser st. Miami
City Postal code Country Position/Affiliation
Alexandria 21411 Egypt Lecturer at NICU, Faculty of Medicine, Alexandria University
REPORTING
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