EUCTR2016-004547-36-HU进行中（未招募）1 期
A RANDOMIZED, OPEN, MULTINATIONAL, MULTICENTRE, 2-PART STUDY IN SPONTANEOUSLY BREATHING PRETERM NEONATES WITH MILD TO MODERATE RESPIRATORY DISTRESS SYNDROME TO INVESTIGATE THE SAFETY, TOLERABILITY AND EFFICACY OF INHALED NEBULIZED PORACTANT ALFA (PORCINE SURFACTANT, CUROSURF®) IN COMPARISON WITH nCPAP ALONE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Neonates must meet all of the following inclusion criteria to be eligible for enrolment into the study:
- •1. Written informed consent obtained by parents/legal representative (according to local regulation) prior to or after birth.
- •2. Inborn neonates from 26+0 to 32+6 weeks of GA, spontaneously breathing and stabilized on nCPAP within 1 hour from birth. In each dose group, neonates with GA from 28+0 to 32+6 will be enrolled first.
- •3. Clinical course consistent with RDS.
- •4. Receiving CPAP pressure 5-8 cm H2O and FiO2 between 0.25 and 0.40 to maintain SpO2 between 88% and 95% for at least 30 minutes between 60 minutes and 12 hours after birth.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 300
- •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
排除标准
- •The presence of any of the following will exclude a neonate from study enrolment:
- •1. Early need for endotracheal intubation for cardiopulmonary resuscitation in delivery room or within 1 hour from birth because of severe RDS [one of the following conditions: rapid (i.e. within 1 h) and persistent (> 30 min) escalation of FiO2 > 0.40 for target SpO2 88-95% in 1 hour, recurrent episodes of apnoea (>2 episodes) requiring positive pressure ventilation (PPV)].
- •2. Respiratory distress not secondary to surfactant deficiency (see APPENDIX 2).
- •3. Use of surfactant prior to study entry and need for endotracheal administration of any other treatment.
- •4. Evidence of severe birth asphyxia (e.g. Apgar score = 5 at 10 minutes after birth, or continued need for resuscitation at 10 minutes after birth, altered neurological state or neonatal encephalopathy).
- •5. Major congenital anomalies.
- •6. Mothers with prolonged rupture of the membranes (> 21 days duration) which could cause complications (in particular severe pulmonary hypoplasia due to oligohydramnios).
- •7. Presence of air leaks identified and known prior to study entry.
- •8. Presence of IVH = III identified and known prior to study entry.
- •9. Hypotension or evidence of hemodynamic instability requiring pharmacological intervention for hemodynamic support.
- •10. Any condition that, in the opinion of the Investigator, would place the neonate at undue risk.
- •11. Participation in another clinical trial of any placebo, experimental medical device or biological substance conducted under the provisions of a protocol on the same therapeutic target; the participation in studies involving diagnostic devices or studies with treatments for different conditions than lung and respiratory function impairments s may be permitted following an agreement with the sponsor. Non interventional observational studies are allowed.
研究者
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