Clinical Trials Logo

Clinical Trial Summary

The aim of this study is to investigate the safety and tolerability of intratracheal administration of two different single doses of CHF 5633 in preterm neonates with RDS in terms of adverse events, adverse drug reactions, hematology and biochemistry values, the incidence of major neonatal morbidities including bronchopulmonary dysplasia (BPD) and mortality.


Clinical Trial Description

The study will be a multicentre, open-label, single escalating dose, per-cohort design. ;


Study Design


Related Conditions & MeSH terms

  • Respiratory Distress Syndrome in Premature Infants
  • Respiratory Distress Syndrome, Adult
  • Respiratory Distress Syndrome, Newborn
  • Syndrome

NCT number NCT01651637
Study type Interventional
Source Chiesi Farmaceutici S.p.A.
Contact
Status Completed
Phase Phase 1
Start date October 2012
Completion date January 23, 2015

See also
  Status Clinical Trial Phase
Terminated NCT02939742 - Does a Rescue Course of Betamethasone in Pregnant Women With PPROM Decrease Neonatal Morbidity? Phase 2/Phase 3
Not yet recruiting NCT04073173 - Stress Assessment With and Without Analgesia During Surfactant Therapy in Preterm Infants. Phase 4
Completed NCT02770976 - Respiratory Pattern During Neurally Adjusted Ventilator Assist (NAVA) in Preterm Infants N/A
Completed NCT02661256 - Effect of Nasal Continuous Positive Airway Pressure on The Pharyngeal Swallow in Neonates N/A
Active, not recruiting NCT02445040 - Safety and Efficacy Study of the Draeger Babylog VN500 Device in HFOV Mode in VLBW Neonates N/A
Completed NCT01962818 - High Frequency Oscillatory Ventilation Combined With Intermittent Sigh Breaths: Effects on Lung Volume Monitored by Electric Tomography Impedance. N/A
Completed NCT02210026 - Seattle-PAP Bubble Nasal CPAP and Work of Breathing Phase 1
Not yet recruiting NCT02200900 - Study of Respiratory Physiology During High Flow Nasal Cannula Treatment in Preterm Neonates. N/A
Completed NCT02396693 - Successful Extubation and Noninvasive Ventilation in Preterm ≤ 1500g Terms N/A
Completed NCT01220687 - Inhaled Nitric Oxide (iNO) as an Adjunct to Neonatal Resuscitation N/A