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.: PACTR202208462613789 Date of Approval: 08/08/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Impact of prophylactic continuous positive airway pressure in the delivery room (DR-CPAP) on neonates <1500g in a low-resource setting: A feasibility trial
Official scientific title Impact of prophylactic continuous positive airway pressure in the delivery room (DR-CPAP) on neonates <1500g in a low-resource setting: A feasibility trial
Brief summary describing the background and objectives of the trial Complications of prematurity are the leading cause of deaths in children under the age of five. The predominant reason for these preterm deaths is respiratory distress syndrome (RDS), with more than 50% of neonates born before 30 weeks of gestation developing RDS. In high income countries (HICs), continuous positive airway pressure (CPAP) has been shown to reduce preterm mortality, reduce the need for mechanical ventilation and reduce chronic lung disease. CPAP is now the standard of care for RDS in HICs, with the option of mechanical ventilation (MV) and artificial surfactant if required.(5) However, in LICs, ventilation, surfactant and CPAP are rarely accessible or affordable leaving limited treatment options for preterm neonates with RDS. In HICs, the use of early prophylactic CPAP, within 15 minutes of delivery, can reduce the need for MV by up to 45% and is now considered a safe alternative to intubation and surfactant for preterm infants. In LICs, even if CPAP is available, access to mechanical ventilation (MV) or surfactant for the treatment of respiratory distress syndrome (RDS) in preterm infants is often limited. Therefore, when CPAP fails in the treatment of RDS, there are limited options for care and RDS is almost always fatal. The reduction in the need for surfactant and MV when early CPAP is used has the potential to reduce mortality from RDS in settings where these advanced treatments are not readily available. The impact of initiating early CPAP in settings where surfactant and MV are lacking has not yet been examined. This trial seeks to evaluate if the introduction of early CPAP in the delivery room is feasible, acceptable and safe. Our future trial seeks to test whether, in a setting without surfactant and ventilation, it can have a significant impact on mortality and morbidity.
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 01/08/2022
Actual trial start date 09/04/2023
Anticipated date of last follow up 31/07/2024
Actual Last follow-up date 01/05/2024
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
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 Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Delivery Room Continuous Positive Airways Pressure DRCPAP DRCPAP applied within 15 minutes of delivery Until CPAP no longer required or neonate is transferred to bubble CPAP Infants in the intervention arm will receive CPAP in the delivery room (DR-CPAP), utilising a portable CPAP device. The DR-CPAP will be applied within 15 minutes of delivery using appropriate sized nasal cannulae. The portable CPAP device chosen delivers an FiO2 0.21 at an average pressure of 6cm H2O with 80% occlusion of the nares when using the preterm sized RAM cannulae. Optional supplementary oxygen will be added to achieve oxygen saturation level of 90-93%. Neonates will be transferred to the neonatal unit on portable CPAP and moved to bCPAP in NNU when a machine becomes available. 50
Control Group standard bCPAP SbCPAP NA NA Those patients in the control arm will receive current standard of care, which is the application of bCPAP Downe’s Score ≥ 4. This will be termed standard bCPAP (S-bCPAP). As per local guidelines the distending pressure will be initiated at 5cm H2O and adjusted between 2-8cm H2O depending on the level of respiratory distress observed. The FiO2 will be adjusted from 0.21–0.95 to achieve oxygen saturations of 90–93% in the preterm neonates. 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Liveborn infants born weighing <1500g • Infants born in Mbale RRH • Mother who can understand English, Luganda, Ateso or Lumasaba • Mother is willing and able to give informed, written consent for participation of her infant in the study. • Mother aged 18 years or above, or those under 18 so long as emancipated. • Infants born weighing ≥1500g • Stillborn infants • Infants born outside of Mbale RRH • Mother who can not understand English, Luganda, Ateso or Lumasaba • Maternal death • Infants with major congenital abnormality e.g. gastroschisis, cyanotic heart disease New born: 0 Day-1 Month 0 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
No 15/08/2022 Mbale Regional Referral Hospital Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Pallisa Road Mbale 921 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Neonatal mortality - death before 28 days of age Daily
Secondary Outcome • Total time on CPAP (days) • High grade (grades III and IV) intraventricular haemorrhage on cranial ultrasound before 7 days of age • Haemodynamically significant patent ductus arteriosus on echocardiogram at 72 hours of age • Significant nasal septal erosions (Superfical erosion or septal necrosis) daily until CPAP is weaned • Pneumothorax on lung ultrasound • Bronchopulmonary dysplasia – need for supplemental oxygen for ≥28 days • Length of hospital stay (days) Daily
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mbale Regional Referral Hospital Pallisa Road Mbale 920 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Joint Global Health Trials Development Grant funded by MRC FCDO NIHR and Wellcome MRC, UK Research and Innovation, Polaris House Swindon Swindon SN2 1FL United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mbale Clinical Research Institute Pallisa Road Mbale 1966 Uganda Research Institute
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kathy Burgoine kathy.burgoine@gmail.com +256778236572 Pallisa Road
City Postal code Country Position/Affiliation
Mbale 1966 Uganda Research Associate
Role Name Email Phone Street address
Public Enquiries Michael Egesa mpegesa_1@yahoo.com +256772633190 Pallisa Road
City Postal code Country Position/Affiliation
Mbale 1966 Uganda Operations Officer
Role Name Email Phone Street address
Scientific Enquiries Peter OlupotOlupot polupotolupot@yahoo.com +256772457217 Pallisa Road
City Postal code Country Position/Affiliation
Mbale 1966 Uganda Executive Direction Mbale Clinical Research Institute
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Summary results will be linked to the trial registration record at completion of the trial. Statistical Analysis Plan,Study Protocol Within 12 months of the study completion Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
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