ISRCTN15915394进行中(未招募)未知
Multicentre, open-label, randomised controlled trial of early surfactant therapy versus expectant management in late preterm and early term infants with respiratory distress
niversity of Leicester0 个研究点目标入组 1,522 人开始时间: 2020年2月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 1,522
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Born at 34+0–38+6 weeks of gestation
- •2. = 24 hours old
- •3. Respiratory distress defined as:
- •3.1. FiO2 = 0.3 and < 0.45 needed to maintain SaO2 = 92%, or
- •3.2. Clinically significant work of breathing, regardless of FiO2
- •4. Clinical decision to provide non-invasive respiratory support
- •5. Written parental informed consent
排除标准
- •1. Major structural or chromosomal abnormality
- •2. No realistic prospect of survival
- •3. Prior intubation and/or surfactant administration
- •4. Known or suspected hypoxic ischaemic encephalopathy
- •5. Congenital abnormality of the upper or lower respiratory tract
- •6. Known or suspected neuromuscular disorder
研究者
相似试验
进行中(未招募)
1 期
Surfactant Or NotRespiratory distress in neonates born at 34 to 38+6 weeks of gestationEUCTR2019-003764-45-GBniversity of Leicester1,522
招募中
不适用
Open-label, multicenter, randomized controlled trials, for comparing remission induction rate of a dose-escalation therapy of methotrexate and an additional combination therapy with bucillamine for naive patients to over 8 mg/weekly of methotrexate.Rheumatoid arthritisJPRN-UMIN000007404KONAMON Study Group90
进行中(未招募)
1 期
A clinical study conducted in several test centers to investigate the safetyof an accelerated high dose escalation schedule for an immune therapy in pediatric patients with hayfever with or without asthma.Patients with moderate to severe seasonal rhinitis or rhinoconjunctivitiswith or without asthmaMedDRA version: 20.1Level: LLTClassification code 10039776Term: Seasonal allergic rhinitisSystem Organ Class: 100000004870MedDRA version: 20.0Level: LLTClassification code 10001726Term: Allergic rhinitis due to pollenSystem Organ Class: 100000004870MedDRA version: 20.0Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisSystem Organ Class: 100000004853MedDRA version: 21.1Level: LLTClassification code 10001705Term: Allergic asthmaSystem Organ Class: 100000004855MedDRA version: 21.1Level: LLTClassification code 10001723Term: Allergic rhinitisSystem Organ Class: 100000004855EUCTR2018-000548-25-DEAllergopharma GmbH & Co. KG87
进行中(未招募)
1 期
Study to investigate the safety of a short (fast) dose escalation in immune therapy with house dust mite allergens as compared to the approved long (slow) dose escalation in adult and adolescent patients with allergic cold (with and w/o asthma).EUCTR2020-004328-41-DEAllergopharma GmbH & Co. KG140
进行中(未招募)
1 期
Study to investigate the safety of a short (fast) dose escalation in immune therapy with house dust mite allergens as compared to the approved long (slow) dose escalation in adult and adolescent patients with allergic cold (with and w/o asthma).moderate to severe allergic rhinitis or rhinoconjunctivitis with or without asthmaMedDRA version: 21.1Level: LLTClassification code 10001723Term: Allergic rhinitisSystem Organ Class: 100000004855MedDRA version: 20.0Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisSystem Organ Class: 100000004853EUCTR2020-004328-41-PLAllergopharma GmbH & Co. KG140
