Funding for this research was provided by:
Bill and Melinda Gates Foundation (INV-026401, INV-039901)
Received: 1 August 2023
Accepted: 7 September 2023
First Online: 19 September 2023
: The sponsor and PIs have obtained approval from the relevant regulatory authorities including SAHPRA (Ref 20221016), University of Cape Town HREC (681/2022), University of the Witwatersrand HREC (insert) and Stellenbosch University (M23/02/004). All major and minor protocol amendments will be submitted to SAHPRA and university ethics committees for approval. Consent to enter the study will be sought from each infant’s mother only after a full explanation has been given, and time allowed for consideration. The PIs will preserve the confidentiality of participants taking part in the study as guided by South Africa’s data protection law, the Protection of Personal Information (POPI) Act 4 of 2013 and will retain all study records and reports for 10 years following completion of the study. Both the sponsor and the PIs will have access to the final trial anonymised dataset for publication. All authors will meet the ICMJE criteria for authorship and no professional writers will be used. The full protocol will be available online for public access. Any relevant data and results may be published or publicly presented by the investigators.Post-trial access is not applicable for the following reasons:• Surfactant is only effective in the first few days of life, thus there will be no long-term treatment requirements.• Aerosolized surfactant is not currently a standard of care anywhere in the world, and should it not be available post-trial, other forms of surfactant delivery (bolus intratracheal surfactant which is the current standard of care) would still be available.• Should the intervention of aerosolized surfactant prove beneficial in our setting (proof of concept), then this study would be the first step in the development of a cheaper, more accessible drug-device combination for infants in LMICs.
: Dr Durand is the chief medical officer at Aerogen Pharma but his contributions to the protocol were of an advisory nature.