Neonatal Respiratory Distress SyndromePhase 2NCT03235986
A Study To InvestigateThe Safety, Tolerability And Efficacy Of Nebulised Curosurf® In Preterm Neonates With Respiratory Distress Syndrome (RDS)
A Phase 2 study testing nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part I), nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part II) and nCPAP (nasal Continuous Positive Airway Pressure) alone (Part I) in people with Neonatal Respiratory Distress Syndrome, run by Chiesi Farmaceutici S.p.A. at 1 site in Italy.
Trial summary
The present study will mainly aim at investigating the safety, tolerability and efficacy of different escalating single doses administration of nebulised Curosurf®, in preterm neonates with RDS (Respiratory Distress Syndrome) during nCPAP. Read more about this study
- Who is it for?
- Ages 28 to 32 weeks
- Conditions the study is for
- Neonatal Respiratory Distress Syndrome
- What is being tested?
- nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part I), nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part II) and nCPAP (nasal Continuous Positive Airway Pressure) alone (Part I)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteItaly
- Study dates
- 28 Aug 2017to 5 May 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Written informed consent obtained by parents/legal representative (according to local regulation) prior to or after birth
- Inborn neonates from 28+0 to 32+6 weeks of gestational age (GA), spontaneously breathing and stabilised on nCPAP
- Clinical course consistent with RDS.
- Receiving CPAP pressure 5-8 centimeter of water (cm H2O) and fraction of inspired oxygen (FiO2) between 0.25 and 0.40 to maintain saturation of peripheral oxygen (SpO2) between 88% and 95% for at least 30 minutes. Randomization should occur between 60 minutes and 12 hours after birth.
Who cannot join
- Early need for endotracheal intubation for cardiopulmonary resuscitation in delivery room or within 1 hour from birth because of severe RDS
- Respiratory Distress not secondary to surfactant deficiency
- Use of surfactant prior to study entry and need for endotracheal administration of any other treatment.
- Major congenital anomalies.
- Evidence of severe birth asphyxia
- Mothers with prolonged rupture of the membranes
Show all 11Show fewer
- Presence of air leaks.
- Presence of IVH (intraventricular hemorrhage ) ≥ III.
- Hypotension or evidence of hemodynamic instability.
- Any condition that, in the opinion of the Investigator, would place the neonate at undue risk.
- Participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
Italy1 site
Prof.Carlo Dani, Coordinating Investigator - Careggi Hospital, Florence (Italy)
Florence, 50134
About this study
Official title: A Randomized, Open, Multinational, Multicentre,2-Part Study In Spontaneously Breathing Preterm Neonates With Mild To Moderate Respiratory Distress Syndrome (RDS) To Investigate The Safety, Tolerability And Efficacy Of Inhaled Nebulised Poractant Alfa (Porcine Surfactant, Curosurf®) In Comparison With Nasal Continuous Positive Airway Pressure (nCPAP) Alone
The present study will mainly aim at investigating the safety, tolerability and efficacy of different escalating single doses administration of nebulised Curosurf®, in preterm neonates with RDS (Respiratory Distress Syndrome) during nCPAP.
Read the detailed description
The study will be conducted in spontaneously breathing preterm neonates with mild to moderate RDS and will consist of two parts:
Part I, with the objective to assess the safety and tolerability of single ascending doses of nebulised Curosurf® ; Part II, with the objective to compare the efficacy of nebulised Curosurf®, administered at two selected doses from part I, during nCPAP, versus nCPAP alone in terms of incidence of respiratory failure in the first 72 hours of life.
- Conditions
- Neonatal Respiratory Distress Syndrome
- Being tested
- nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part I), nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part II), nCPAP (nasal Continuous Positive Airway Pressure) alone (Part I), nCPAP (nasal Continuous Positive Airway Pressure) alone (Part II)
- Keywords
- RDS
- Medical subject headings
- Respiratory Distress Syndrome, Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part I)Drug
Single ascending doses of Curosurf® administered through nebulisation to neonates receiving nCPAP (Part I)
nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part II)Drug
Two doses of Curosurf® administered through nebulisation to neonates receiving nCPAP (Part II)
nCPAP (nasal Continuous Positive Airway Pressure) alone (Part I)Other
Nasal continuous positive airway pressure alone
nCPAP (nasal Continuous Positive Airway Pressure) alone (Part II)Other
nasal continuous positive airway pressure alone
| Study group | Role | What they receive |
|---|---|---|
| nCPAP+ Nebulised Curosurf® | Experimental | Curosurf® administered through nebulization Receives: Drug: nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part I); Drug: nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part II) |
| nCPAP alone (control) | Other | Standard of care, respiratory support used also during experimental arms Receives: Other: nCPAP (nasal Continuous Positive Airway Pressure) alone (Part I); Other: nCPAP (nasal Continuous Positive Airway Pressure) alone (Part II) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of neonates with respiratory failure
Respiratory failure defined as: need for endotracheal surfactant administration and/or mechanical ventilation
Measured: in the first 72 hours of life
Adverse Events
Any untoward medical occurrence in a clinical trial neonate administered a medicinal product and which does not necessarily have a casual relationship with the treatment
Measured: discharge or 36 weeks post menstrual age (PMA), whichever comes first
Adverse Drug Reactions
Any untoward and unintended responses to an investigational product related to any dose administered
Measured: discharge or 36 weeks post menstrual age (PMA), whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start28 Aug 2017
- Primary completion5 May 2020
- Study completion5 May 2020
Why it stopped: Change in the benefit-risk balance
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part I is an ascending dose scheme of IMP versus nCPAP alone. Part II is a parallel group with 2 doses of IMP versus nCPAP alone. In part II, one additional dose may be administered between 3 and 12 hours after the start of the first dose.
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlo Dani, MD, Principal investigator, Careggi Hospital, Florence (Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03235986
- Sponsor's protocol ID
- CCD-01534CA1-01
- Other IDs
- 2016-004547-36, 2016
- Status last verified
- Mar 2022
- First submitted
- 26 Jul 2017
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dani C, Talosi G, Piccinno A, Ginocchio VM, Balla G, Lavizzari A, Stranak Z, Gitto E, Martinelli S, Plavka R, Krolak-Olejnik B, Lista G, Spedicato F, Ciurlia G, Santoro D, Sweet D; CURONEB Study Group. A Randomized, Controlled Trial to Investigate the Efficacy of Nebulized Poractant Alfa in Premature Babies with Respiratory Distress Syndrome. J Pediatr. 2022 Jul;246:40-47.e5. doi: 10.1016/j.jpeds.2022.02.054. Epub 2022 Mar 5.
PubMed 35257740
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open, Multinational, Multicentre,2-Part Study In Spontaneously Breathing Preterm Neonates With Mild To Moderate Respiratory Distress Syndrome (RDS) To Investigate The Safety, Tolerability And Efficacy Of Inhaled Nebulised Poractant Alfa (Porcine Surfactant, Curosurf®) In Comparison With Nasal Continuous Positive Airway Pressure (nCPAP) Alone
- ClinicalTrials.gov ID
- NCT03235986
- Acronym / sponsor ID
- CCD-01534CA1-01
- Conditions
- Neonatal Respiratory Distress Syndrome
- Keywords
- RDS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in the benefit-risk balance
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 5 May 2020 (actual)
- Study completion
- 5 May 2020 (actual)
- First posted
- 1 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study will mainly aim at investigating the safety, tolerability and efficacy of different escalating single doses administration of nebulised Curosurf®, in preterm neonates with RDS (Respiratory Distress Syndrome) during nCPAP.
Detailed description
The study will be conducted in spontaneously breathing preterm neonates with mild to moderate RDS and will consist of two parts:
Part I, with the objective to assess the safety and tolerability of single ascending doses of nebulised Curosurf® ; Part II, with the objective to compare the efficacy of nebulised Curosurf®, administered at two selected doses from part I, during nCPAP, versus nCPAP alone in terms of incidence of respiratory failure in the first 72 hours of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Part I is an ascending dose scheme of IMP versus nCPAP alone. Part II is a parallel group with 2 doses of IMP versus nCPAP alone. In part II, one additional dose may be administered between 3 and 12 hours after the start of the first dose.
| Arm | Type | Receives |
|---|---|---|
| nCPAP+ Nebulised Curosurf® | Experimental | Drug: nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part I), Drug: nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part II)Curosurf® administered through nebulization |
| nCPAP alone (control) | Other | Other: nCPAP (nasal Continuous Positive Airway Pressure) alone (Part I), Other: nCPAP (nasal Continuous Positive Airway Pressure) alone (Part II)Standard of care, respiratory support used also during experimental arms |
Who may qualify
- Ages
- 28 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Written informed consent obtained by parents/legal representative (according to local regulation) prior to or after birth
- Inborn neonates from 28+0 to 32+6 weeks of gestational age (GA), spontaneously breathing and stabilised on nCPAP
- Clinical course consistent with RDS.
- Receiving CPAP pressure 5-8 centimeter of water (cm H2O) and fraction of inspired oxygen (FiO2) between 0.25 and 0.40 to maintain saturation of peripheral oxygen (SpO2) between 88% and 95% for at least 30 minutes. Randomization should occur between 60 minutes and 12 hours after birth.
Key exclusion criteria (11 listed)
- Early need for endotracheal intubation for cardiopulmonary resuscitation in delivery room or within 1 hour from birth because of severe RDS
- Respiratory Distress not secondary to surfactant deficiency
- Use of surfactant prior to study entry and need for endotracheal administration of any other treatment.
- Major congenital anomalies.
- Evidence of severe birth asphyxia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part I)Single ascending doses of Curosurf® administered through nebulisation to neonates receiving nCPAP (Part I) | Drug | nCPAP+ Nebulised Curosurf® |
| nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part II)Two doses of Curosurf® administered through nebulisation to neonates receiving nCPAP (Part II) | Drug | nCPAP+ Nebulised Curosurf® |
| nCPAP (nasal Continuous Positive Airway Pressure) alone (Part I)Nasal continuous positive airway pressure alone | Other | nCPAP alone (control) |
| nCPAP (nasal Continuous Positive Airway Pressure) alone (Part II)nasal continuous positive airway pressure alone | Other | nCPAP alone (control) |
Primary outcome
Percentage of neonates with respiratory failure
Time frame: in the first 72 hours of life
Respiratory failure defined as: need for endotracheal surfactant administration and/or mechanical ventilation
Adverse Events
Time frame: discharge or 36 weeks post menstrual age (PMA), whichever comes first
Any untoward medical occurrence in a clinical trial neonate administered a medicinal product and which does not necessarily have a casual relationship with the treatment
Adverse Drug Reactions
Time frame: discharge or 36 weeks post menstrual age (PMA), whichever comes first
Any untoward and unintended responses to an investigational product related to any dose administered
Results and safety
The study was stopped early (reason given: Change in the benefit-risk balance). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Results publication: PubMed 35257740Dani C, Talosi G, Piccinno A, Ginocchio VM, Balla G, Lavizzari A, Stranak Z, Gitto E, Martinelli S, Plavka R, Krolak-Olejnik B, Lista G, Spedicato F, Ciurlia G, Santoro D, Sweet D; CURONEB Study Group. A Randomized, Controlled Trial to Investigate the Efficacy of Nebulized Poractant Alfa in Premature Babies with Respiratory Distress Syndrome. J Pediatr. 2022 Jul;246:40-47.e5. doi: 10.1016/j.jpeds.2022.02.054. Epub 2022 Mar 5.
- Study Record on EU Clinical Trials Register including resultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Neonatal Respiratory Distress Syndrome
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlo Dani, MD principal investigator
Careggi Hospital, Florence (Italy)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part I), nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part II) and nCPAP (nasal Continuous Positive Airway Pressure) alone (Part I) in people with Neonatal Respiratory Distress Syndrome, run by Chiesi Farmaceutici S.p.A. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Change in the benefit-risk balance). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of neonates with respiratory failure (time frame: in the first 72 hours of life). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03235986, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.