Efficacy of recombinant human club (clara) cell 10kDa protein (CC10) administered to premature neonates with respiratory distress syndrome.

Therabron Therapeutics Inc.0 个研究点目标入组 88 人开始时间: 2015年7月27日最近更新: 2018年9月10日

试验速览

暂无简介。

•Age = 24 hours;
•Birthweight between 600 and 1,250 grams;
•Gestational age 24-29 weeks (not less than 24 weeks); at birth based on best estimate using obstetrical sonography (first or second trimester), solid dating criteria, or Ballard examination;
•Birthweight appropriate for gestational age;
•5 minute Apgar score >5;
•Diagnosis of neonatal RDS based on clinical and radiographic criteria;
•Requiring intubation and mechanical ventilation for treatment of RDS;
•Received at least one dose of surfactant (prophylaxis or rescue) or the decision to treat with surfactant has already been made (e.g. infant is intubated or in the process of being intubated and/or surfactant has been prescribed); and
•Written informed consent is obtained from the infant’s parent or legal guardian prior to enrollment of the patient and agrees to all study-related procedures and evaluations, including those required after hospital discharge.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 88
•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

•5 minute Apgar score of = 5; except in cases where the subject’s Apgar score is = 5 at 5 minutes, normalizes by 10 minutes, no acidosis is present on cord blood gas and the neonatal depression is thought to be due to maternal anesthesia or other drug exposure such as MgSO4.
•Major congenital abnormalities (chromosomal, renal, cardiac, hepatic, neurologic, or pulmonary malformations; minor anomalies such as cleft lip/palate are permitted);
•Evidence of severe neonatal depression (as defined by cord blood pH = 7.00 and/or an Apgar score of < 4 at 10 minutes);
•Evidence of congenital infection (bacterial or non-bacterial) ;
•Requires a major surgical procedure prior to administration of Study drug
•Enrollment in any other study involving administration of another investigational drug;
•Any condition which could preclude receiving study drug or performing any study-related procedures;
•Use of postnatal corticosteroids prior to administration of rhCC10, except as specified in the protocol;
•Use of inhaled nitric oxide prior to administration of rhCC10;
•Mother is known to be seropositive for HIV or HTLV-1 (per maternal medical records);
•Parent or guardian is unable or unwilling to complete the study diary after hospital discharge;
•Parent or guardian is unable to bring the infant back to the study center for follow-up evaluations after discharge.

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