Neonatal Respiratory Distress Syndrome Clinical Trial
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
Verified date | March 2022 |
Source | Chiesi Farmaceutici S.p.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 166 |
Est. completion date | May 5, 2020 |
Est. primary completion date | May 5, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 28 Weeks to 32 Weeks |
Eligibility | Inclusion Criteria: 1. Written informed consent obtained by parents/legal representative (according to local regulation) prior to or after birth 2. Inborn neonates from 28+0 to 32+6 weeks of gestational age (GA), spontaneously breathing and stabilised on nCPAP 3. Clinical course consistent with RDS. 4. 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. Exclusion Criteria: 1. Early need for endotracheal intubation for cardiopulmonary resuscitation in delivery room or within 1 hour from birth because of severe RDS 2. Respiratory Distress not secondary to surfactant deficiency 3. Use of surfactant prior to study entry and need for endotracheal administration of any other treatment. 4. Major congenital anomalies. 5. Evidence of severe birth asphyxia 6. Mothers with prolonged rupture of the membranes 7. Presence of air leaks. 8. Presence of IVH (intraventricular hemorrhage ) = III. 9. Hypotension or evidence of hemodynamic instability. 10. Any condition that, in the opinion of the Investigator, would place the neonate at undue risk. 11. Participation in another clinical trial |
Country | Name | City | State |
---|---|---|---|
Italy | Prof.Carlo Dani, Coordinating Investigator - Careggi Hospital, Florence (Italy) | Firenze |
Lead Sponsor | Collaborator |
---|---|
Chiesi Farmaceutici S.p.A. |
Italy,
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 Eff — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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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