BridgeMD
Tests treatment safety and results for Bronchopulmonary Dysplasia
Official title Efficacy and Safety of Zelpultide Alfa in Preterm Neonates at High Risk of Developing Bronchopulmonary Dysplasia (BPD)
ClinicalTrials.gov ID: NCT06897839
What this study is testing
What is Zelpultide alfa?
Zelpultide alfa is an investigational medicine, being studied as a potential treatment for bronchopulmonary dysplasia.
Also referred to as AT-100, rhSP-D.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a randomized, parallel-group, double-blind, placebo-controlled multicenter phase 2b/3 study with an adaptive seamless design. The goal fo this study is to determine if an investigational drug, Zelpultide Alfa, can reduce the occurrence of Bronchopulmonary Dysplasia (BPD) in extremely premature babies.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 96
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 birth.
- 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...
- 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 \ 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 diaphragmatic hernia,
- Omphalocele or gastroschisis, esophageal atresia,
- Known or suspected cyanotic congenital heart disease (ie, tetralogy of fallot, transposition of the great arteries, etc).
See the full eligibility criteria
- 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 birth.
- 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. people...
- Informed consent and personal information authorization form signed by the subject's parent(s) or legal guardian(s).
- Birth weight \ 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 diaphragmatic hernia,
- Omphalocele or gastroschisis, 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...
- 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.
Where it's taking place
- Buenos Aires, Argentina
- Antwerp, Belgium
- Brussels, Belgium
- Leuven, Belgium
- Liège, Belgium
- Lille, France
- Nancy, France
- Nice, France
- Paris, France
- Poissy, France
- Dresden, Germany
- Freiburg im Breisgau, Germany
- Regensburg, Germany
- Haifa, Israel
- Jerusalem, Israel
- Safed, Israel
- Bologna, Italy
- Genova, Italy
- Milan, Italy
- Naples, Italy
+ 17 more site(s).
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 minutes to 96 hours. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Buenos Aires, Argentina; Antwerp, Belgium; Brussels, Belgium; Leuven, Belgium; Liège, Belgium; Lille, France and 31 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.