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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202307490670785 Date of Registration: 18/07/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Neonatal Interventional Nebulized Surfactant for Preterm Infants with RDS (Neo-INSPIRe)
Official scientific title A South African, multicenter, phase 2, non-blinded, randomized controlled trial to determine if aerosolized surfactant plus continuous positive airway pressure (CPAP) compared to CPAP alone can improve the course of infants with respiratory distress syndrome (RDS) by decreasing their need for intratracheal bolus surfactant in the first 72 hours of age
Brief summary describing the background and objectives of the trial Respiratory distress syndrome in preterm infants is an important cause of morbidity and mortality. Less invasive methods of surfactant administration, along with the use of continuous positive airway pressure (CPAP), have improved outcomes of preterm infants. Aerosolized surfactant can be given without the need for airway instrumentation and may be employed in areas where these skills are scarce. Recent trials from high-resourced countries utilising aerosolized surfactant have had a low quality of evidence and varying outcomes. This is a South African, multicentre, phase 2, non-blinded, randomized controlled trial. The purpose of this study is to determine whether aerosolized surfactant (AeroFactTM, SF-RI 1 surfactant for inhalation, delivered by a dedicated delivery system) can improve the course of infants with respiratory distress syndrome (RDS) on nasal continuous positive airway pressure (nCPAP) by reducing the need for intratracheal bolus surfactant instillation in the first 72 hours of age. Eligible participants are inborn preterm infants between 900 – 1999 g and 27 – 34 weeks gestation with a persistent FiO2 of 0.25 – 0.35 on nCPAP between 2 – 24 hours of age. Infants randomized to the Intervention group will receive up to 2 doses of aerosolized surfactant while on nCPAP. Infants randomized to the Control group will continue on nCPAP alone and will not receive aerosolized surfactant as an intervention. Infants in both the Intervention and Control groups with a persistent FiO2 > 0.40 sustained for at least 15 minutes will be regarded as meeting failure criteria and will be eligible to receive intratracheal bolus surfactant instillation.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) NeoINSPIRe
Disease(s) or condition(s) being studied Paediatrics,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 14/05/2023
Actual trial start date 01/06/2023
Anticipated date of last follow up 31/12/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 232
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
270320 SANCTR
APCAFCLN004 Aerogen Pharma
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 Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Aerofact Surfactant (SF-RI 1) 216mg/kg. May receive a second dose 30mins after the first dose is completed The dose takes approximately 2-4 hours to administer AeroFactTM (Aerogen Pharma) is an investigational drug/device combination product consisting of bovine-origin surfactant SF-RI 1 and a vibrating mesh nebulizer with a nasal interface. 116
Control Group CPAP The oxygen will be administered as per standard unit protocol As per standard unit protocol Normal standard of care (continuous positive airway pressure) 116 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inborn ● Birth Weight of 900 - 1999 g ● 27 – 34 weeks gestational age ● 2 - 24 hours of age at time of randomization ● Persistent fractional inspired oxygen (FiO2) of 0.25 – 0.35 on nCPAP at 5-7 cmH2O to maintain peripheral oxygen saturation of 90 -95%. FiO2 requirement needs to be sustained for at least 15 minutes. Administration of inotropes and/or intubation prior to enrolment (in the delivery room or NICU) ● 5-minute Apgar score ≤ 5 ● Prior instillation of intratracheal bolus surfactant ● Pneumothorax that requires needle thoracentesis or insertion of an intercostal chest drain ● Life-threatening congenital anomaly ● Known or suspected chromosomal abnormality ● Known or suspected congenital infection including syphilis, cytomegalovirus or toxoplasmosis. New born: 0 Day-1 Month 0 Day(s) 3 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 08/06/2023 Stellenbosch University Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Tygerberg campus, University of Stellenbosch Cape Town 7505 South Africa
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 10/02/2023 University of Cape Town Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
E52, Old Main Building, Groote Schuur Hospital Cape Town 7925 South Africa
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 17/01/2023 University of the Witwatersrand Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Research Office, Faculty of Health Sciences, Phillip Tobias Building, Offices 301-304, 3rd Floor, Cnr York Road and 29 Princess of Wales Terrace, Parktown, 2193 Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of infants requiring intratracheal bolus surfactant administration in the first 72 hours of age in each study group 72 hours
Secondary Outcome Proportion of infants meeting failure criteria in the first 72 hours of age in each group 72 hours
Secondary Outcome Number of hours on mechanical ventilation during hospital stay between groups Discharge from neonatal unit
Secondary Outcome Number of days on CPAP and/or HFNC, and supplementary oxygen during hospital stay between groups Discharge from neonatal unit
Secondary Outcome Incidence of adverse events and usually reported selected comorbidities of prematurity Birth until discharge from neonatal unit
Secondary Outcome Incidence of BPD in survivors at 36 weeks postmenstrual age between groups 36 weeks postmenstrual age
Secondary Outcome Incidence of BPD or death at 36 weeks postmenstrual age between groups 36 weeks postmenstrual age
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Groote Schuur Neonatal Nursery Groote Schuur Hospital, Observatory Cape Town 7925 South Africa
Tygerberg Neonatal Nursery Tygerberg Hospital, Parow Cape Town 7505 South Africa
Baragwanath Neonatal Nursery Baragwanath Hospital, Soweto Johannesburg 1862 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Aerogen Pharma 1660 S Amphlett Boulevard, Suite 360 San Mateo 94402 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Aerogen Pharma 1660 S Amphlett Boulevard, Suite 360 San Mateo 94402 United States of America Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Lloyd Tooke lloyd.tooke@uct.ac.za +27834562575 Old Main Building, Groote Schuur Hospital
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Neonatologist
Role Name Email Phone Street address
Public Enquiries Ilse Lategan ilse.lategan@gmail.com +27724943336 Old Main Building, Groote Schuur Hospital
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Research Officer
Role Name Email Phone Street address
Scientific Enquiries Michael Harrison mc.harrison@uct.ac.za +27822542654 Old Main Building, Groote Schuur Hospital
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Head of Neonatology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 2 years Controlled access may be allowed depending on the sponsor's consideration
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