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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004547-36 | EudraCT Number |
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Change in the benefit-risk balance
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nCPAP+ Nebulised Curosurf® | Experimental | Curosurf® administered through nebulization |
|
| nCPAP alone (control) | Other | Standard of care, respiratory support used also during experimental arms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of neonates with respiratory failure | Respiratory failure defined as: need for endotracheal surfactant administration and/or mechanical ventilation | 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 | 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 | discharge or 36 weeks post menstrual age (PMA), whichever comes first |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlo Dani, MD | Careggi Hospital, Florence (Italy) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prof.Carlo Dani, Coordinating Investigator - Careggi Hospital, Florence (Italy) | Florence | 50134 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35257740 | Result | 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. |
| Label | URL |
|---|---|
| Study Record on EU Clinical Trials Register including results | View source |
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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.
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| 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 |
|
| ID | Term |
|---|---|
| D012127 | Respiratory Distress Syndrome, Newborn |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| D012847 | Single Person |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
| D017533 | Marital Status |
| D005191 | Family Characteristics |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D012959 | Socioeconomic Factors |
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