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ZELA trial: Phase 2b/3 Multicenter Study to Evaluate the Efficacy and Safety of Zelpultide Alfa in Preterm Neonates at High Risk of Developing Bronchopulmonary Dysplasia (BPD) compared to standard of care (SOC)
EU CTIS ID: 2024-513420-41-00
What this study is testing
Part 1 (Phase 2b / Dose Selection): To explore the efficacy and safety of zelpultide alfa at two dose levels (4 mg/kg and 6 mg/kg) added to standard of care (SOC) compared to placebo (air-sham) added to SOC, in preterm neonates at high risk of developing BPD, to support dose selection for Part 2 (Phase 3). Part 2 (Phase 3 / Confirmatory Phase): To compare and confirm the efficacy of zelpultide alfa (at the selected dose) added to SOC versus placebo (air-sham) added to SOC in terms of incidence of grade 2 and grade 3 BPD and death in neonates at high risk for developing BPD.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Born between gestational age (GA) 22 0/7 to 27 6/7 weeks, inclusive.
- Received at least 1 dose of SOC-indicated animal-derived pulmonary surfactant treatment after birt
- Intubated and on invasive mechanical ventilation per SOC.
- Able to receive the first dose of zelpultide alfa or air-sham at least 15 min after the surfactant administration but within 96 h of birth and within 48 h from the start of invasive mechanical ventilation. • Subjects extubated and re-intubated after their pulmonary surfactant dose(s) are eligible as long as the inclusion criteria are met.
- Informed consent and personal information authorization form signed by the subject’s parent(s) or legal guardian(s).
You likely can't join if
- Birth weight < 400 g or > 1,500 g.
- Major apparent congenital abnormalities impacting cardio and pulmonary function identified before randomization, such as, but not limited to: • Clinically relevant Potter-like syndrome and any pulmonary congenital anomalies, • Clinically relevant congenital hernia, • Omphalocele or diaphragmaticgastroschisis, esophageal atresia,• Known or suspected cyanotic congenital heart disease (ie, tetralogy of fallot, transposition of the great arteries, etc).
- Active do no resuscitate (DNR) order in place.
- History of allergy or sensitivity to any surfactant or any component of zelpultide alfa.
- Concurrent enrollment in any clinical study that utilizes treatments (investigational medical products or devices) outside of SOC or participation in studies within the last 30 days (or 5 half-lives of an IMP) prior to birth (for the mother) or up to week 36 PMA.
- Any condition or situation that, in the Investigator’s judgement, puts the neonate at significant risk, could confound the study results, or may interfere significantly with the neonate’s participation in the study.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.