A phase 1b randomized, multicenter, dose determination trial of zelpultide alfa (recombinant human surfactant protein D) in preterm neonates at high risk of developing bronchopulmonary dysplasia
This study endorses the safety and tolerability of zelpultide alfa up to 6 mg/kg (≤7 days) and reinforces the need for further clinical development of zelpultide alfa as a therapy for preventing BPD.<b>Clinical Trial Registration</b>: https://clinicaltrials.gov/study/NCT04662151?cond=BPD&term=At-100&rank=1, identifier NCT04662151.
Authors
- Elisenda Moliner-Calderón (ORCID: https://orcid.org/0000-0001-5631-2888)
- Brenda Bradley Poindexter (ORCID: https://orcid.org/0000-0002-1013-9896)
- Raquel Arroyo (ORCID: https://orcid.org/0000-0003-0612-3928)
- Almudena Alonso‐Ojembarrena (ORCID: https://orcid.org/0000-0002-2413-9758)
- Marta Aguar‐Carrascosa
- Helen Healy (ORCID: https://orcid.org/0000-0003-0519-4759)
- Samia Aleem (ORCID: https://orcid.org/0000-0003-0291-7608)
- María del Mar Serrano-Martín
- Máximo Vento (ORCID: https://orcid.org/0000-0003-0061-4742)
Institutions
- Beth Israel Deaconess Medical Center (US)
- Emory University (US)
- Hospital de Sant Pau (ES)
- Hospital Universitari i Politècnic La Fe (ES)
- Hospital Regional Universitario de Málaga (ES)
- Leitat Technological Center (ES)
- Biomedical Research and Innovation Institute of Cadiz (ES)
- Duke Medical Center (US)
- Hospital Universitario Puerta del Mar (ES)
- Children's Healthcare of Atlanta (US)
- Airtren (Spain) (ES)
- Instituto de Investigación Sanitaria La Fe (ES)
Publication Details
- Journal
- Frontiers in Pediatrics
- Published
- 2025-09-12
- DOI
- https://doi.org/10.3389/fped.2025.1639573
- Citations
- 4
- Primary Topic
- Neonatal Respiratory Health Research
- Type
- article
- Field-Weighted Citation Impact
- 6.07