A FIRST IN HUMAN CLINICAL STUDY ON THE SAFETY AND TOLERABILITY OF TWO ESCALATING SINGLE DOSES OF CHF 5633 (SYNTHETIC SURFACTANT) IN PRETERM NEONATES WITH RESPIRATORY DISTRESS SYNDROME

Chiesi Farmaceutici S.p.A.0 个研究点目标入组 40 人开始时间: 2013年9月16日最近更新: 2015年8月4日

试验速览

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•1. Written informed consent obtained by parents/legal representative (according to local regulation) prior to any study-related procedures
•2. Inborn and outborn, preterm neonates of either sex with a gestational age of 27 weeks up to 33 weeks+6
•3. Clinical and radiological findings typical of RDS
•4. Test treatment administration within 48 hours from birth
•5. Requirement for endotracheal surfactant administration
•6. Fraction of inspired oxygen (FiO2) =0.35 to maintain SpO2 between 90–95 %
•7. Documentation of normal cranial ultrasound scan.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 40
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Use of surfactant prior to study entry and need for intratracheal administration of any other treatment (e.g. nitric oxide)
•2. Known genetic or chromosomal disorders, major congenital anomalies (cardiac malformations, myelomeningocele etc)
•3. Maternal drug abuse (heroin, methadone, methamphetamine, or cocaine) or significant alcohol consumption during pregnancy
•4. Strong suspicion of congenital pneumonia/infection, sepsis
•5. Evidence of severe birth asphyxia or a 5 minutes Apgar score =3
•6. Presence of air leaks prior to study entry
•7. Neonatal seizures prior to study entry
•8. Mothers with prolonged rupture of the membranes (> 3 weeks duration)
•9. Any condition that, in the opinion of the Investigator, would place the neonate at undue risk
•10. Participation in another clinical trial of any placebo, drug or biological substance conducted under the provisions of a protocol.

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