EUCTR2019-004720-38-IT进行中（未招募）1 期
Effects of late surfactant treatment delivered after a recruitment maneuver on respiratory outcomes in extremely low gestational age newborns: a randomized controlled trial – LATE-REC-SURF Trial. - LATE-REC-SURF
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE0 个研究点目标入组 20 人开始时间: 2020年10月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
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
- •1.Extremely low gestational age newborn infants (GA < 28 weeks) – gestational age matching between maternal dates and/or early antenatal ultrasound
- •2.Singleton or multiple birth
- •3.Postnatal age between 7 and 10 days
- •4.Invasive mechanical ventilation still needed
- •5.Fraction of inspired oxygen (FiO2) of more than 0.30 and/or an oxygenation index of 8 or more for at least 6 hours
- •6.Stable cardiovascular condition
- •7.Informed consent form signed by parents or legal guardian
- •Are the trial subjects under 18? yes
- •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
排除标准
- •1.Major congenital malformation (i.e., infants with genetic, metabolic or endocrine disorder diagnosed before enrolment)
- •2.High index of suspicion of infection before enrolment
- •3.Neurological conditions that might contraindicate extubation
- •4.Inotropic agents needed
- •5.Pneumothorax
- •6.Hemodynamically significant ductus arteriosus
- •7.Surgical intervention within the past 72 hours
- •8.Partecipation in another interventional clinical study that may interfere with the results of this trial
研究者
相似试验
已完成
2 期
Effect of prophylactic surfactant on outcome of premature neonateRespiratory distress syndrom of newborn.Respiratory distress syndrome of newbornIRCT138905104486N1Kermanshah University of Medical Sciences182
招募中
3 期
The effect of surfactant on clinical outcome of patients with COVID-19Mortality of Patients from COVID-19.COVID-19U07.1IRCT20091201002804N12Shahid Beheshti University of Medical Sciences60
尚未招募
4 期
Comparison of surfactant delivery methods - Endotracheal tube vs Laryngeal mask airwayCTRI/2023/07/054608Srikanth kandi
招募中
2 期
Late Surfactant After a Recruitment Maneuver in Extremely Low Gestational Age Newborns - LATE-REC-SURF TrialChronic Pulmonary Insufficiency of PrematurityBronchopulmonary DysplasiaNCT04825197VENTO GIOVANNI20
进行中（未招募）
1 期
The efficacy and mechanism of surfactant therapy for critically ill infants with bronchiolitis: the Bronchiolitis Endotracheal Surfactant Study (BESS)Critical Illness due to Bronchiolitis of infancy requiring conventional invasive Mechanical Ventilation (MV) Diagnosis of bronchiolitis per clinical criteria defined in national guidance NICE-NG9.MedDRA version: 20.1 Level: PT Classification code 10038718 Term: Respiratory syncytial virus bronchiolitis System Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.1 Level: PT Classification code 10065188 Term: Lower respiratory tract infection viral System Organ Class: 10021881 - Infections and infestationsEUCTR2018-001169-18-GBniversity Of Liverpool284