A RANDOMIZED CONTROLLED STUDY TO EVALUATE THE EFFICACY OF A SUPPLEMENTAL DOSE OF CUROSURF IN PRE-TERM INFANTS ON MECHANICAL VENTILATION FOR RESPIRATORY DISTRESS SYNDROME RDS IN PREVENTING EXTUBATION FAILURE - ND

CHIESI0 个研究点目标入组 200 人开始时间: 2006年4月21日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•BW between 500 and 1500 g. In-born and out-born male or female pre term neonates. Diagnosis of RDS and treatment with either prophylactic or rescue Curosurf maximum of 2 doses . Endotracheally intubated at 3 days, with planned extubation between 72 and 240 hours of age. No potentially life threatening conditions unrelated to immaturity. Written informed parental consent for their infant to take part in the study see Appendix II .
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•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

•Patients will be excluded from this study if they meet ANY of the following criteria American Pediatric Gross Assessment Record score below 3 at 5 minutes of age. Delivered by mothers with rupture of the membranes for more than 3 weeks. Known genetic or chromosomal disorders. Receiving nitric oxide. Major conditions of prematurity which can affect respiratory drive or respiratory outcomes, already present before extubation, such as o pulmonary hemorrhage or intracranial bleeding of grade 3 or higher, o necrotising enterocolitis NEC , o patent ductus arteriosus PDA , o clinically severe infection. NOTE PDA and clinically severe infection are contra indications to extubation. Participation in another clinical study of any placebo, drug, biological, or device conducted under the provision of a protocol.

发起方

CHIESI