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2020年10月21日
适应症Preterm infants still requiring mechanical ventilation at 7-10 days of life.MedDRA version: 20.0Level: LLTClassification code 10076729Term: Very preterm infantSystem Organ Class: 100000004868Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
相关药物CUROSURF
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Preterm infants still requiring mechanical ventilation at 7-10 days of life.
- 发起方
- FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
- 入组人数
- 20
- 状态
- 进行中（未招募）
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
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
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
结局指标
主要结局
未指定
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 airwayHealth Condition 1: P220- Respiratory distress syndrome of newbornCTRI/2023/07/054608Srikanth kandi
招募中
2 期
Late Surfactant After a Recruitment Maneuver in Extremely Low Gestational Age Newborns - LATE-REC-SURF TrialBronchopulmonary DysplasiaChronic Pulmonary Insufficiency of PrematurityNCT04825197VENTO 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 infestationsTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]EUCTR2018-001169-18-GBniversity Of Liverpool284