EUCTR2013-001998-24-DE进行中（未招募）1 期
A prospective, multicenter, double blind, placebo-controlled, two-arm parallel group phase 3 trial to evaluate the effect of early postnatal additional high dose oral vitamin A supplementation of 5000 IU/kg/d versus placebo for 28 days for preventing bronchopulmonary dysplasia (BPD) or death in extremely-low-birth-weight (ELBW) infants. - NeoVitaA
Saarland University0 个研究点目标入组 914 人开始时间: 2014年5月16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
- 914
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 with a birth weight <1000 g.
- •Neonates with a gestational age < 32+0 weeks at time of inclusion into the Trial.
- •Who receive any oxygen supplementation or respiratory support after admission to the NICU
- •within 72 hours following birth.
- •Who (will) receive a basic VA supplementation of 1000 IU/kg body weight/day (7000 IU/kg
- •body weight/week).
- •Postnatal age <72 hours of life.
- •Minimal/enteral feeds (>2.5 / <10 ml/kg body weight per day) commenced.
- •Signed and dated informed parental or legal representative’s consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1000
- •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 abnormalities.
- •Congenital nonbacterial infection with overt signs at birth.
- •Terminal illness as evidenced by pH <7.0 for >2 hours or persistent bradycardia (heart rate
- •<100 bpm) associated with hypoxia for >2 hours.
- •Birth weight <400 g.
- •Participation in another clinical trial according to German Drug Law (AMG).
研究者
相似试验
进行中（未招募）
1 期
Oral vitamin A supllementation versus placebo for preventing for 28 days for preventing bronchopulmonary dysplasia (BPD) or death in extremely-low-birth-weight (ELBW) infants.Preventing bronchopulmonary dysplasia (BPD) or death in extremely-low-birth-weight (ELBW) infants.EUCTR2013-001998-24-ATSaarland University914
已完成
3 期
A prospective, multicenter, double blind, placebo-controlled, two-arm parallel group phase 3 trial to evaluate the effect of early postnatal additional high dose oral vitamin A supplementation of 5000 IU/kg/d versus placebo for 28 days for preventing bronchopulmonary dysplasia (BPD) or death in extremely-low-birth-weight (ELBW) infants.P27.1Bronchopulmonary dysplasia originating in the perinatal periodDRKS00006541niversität des Saarlandes, Saarbrücken, Deutschland914
进行中（未招募）
1 期
Efficacy and Safety of sublingual immunotherapy with LAIS® Grass pollen tablets in patients with seasonal grass pollen-induced allergic rhinoconjunctivitisseasonal grass pollen-induced allergic rhinoconjunctivitisMedDRA version: 20.0Level: LLTClassification code 10036019Term: Pollen allergySystem Organ Class: 100000004870MedDRA version: 20.0Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisSystem Organ Class: 100000004853EUCTR2019-001532-65-ITOFARMA S.P.A.264
已完成
3 期
Clinical study to find the effectiveness of Meniphib tablets in female patients suffering from premenstrual syndrome.CTRI/2021/02/031249Bhargava Phytolab100
已完成
3 期
study to find the effectiveness and safety of Sinuset tablets in patients suffering from Sinusitis and/or Allergic RhinitisCTRI/2021/02/031045BHARGAVA PHYTOLAB100