EUCTR2014-002624-28-FR进行中（未招募）1 期
A Multi-center, Double-blind, Randomized, Placebo Controlled Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption due to GI Immaturity in Preterm Infants. - A Study to Assess the Efficacy and Safety of NTRA-2112 in Preterm Infants
utrinia0 个研究点目标入组 300 人开始时间: 2018年10月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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
- •1. Pre-term infants 26 and up to 32 weeks gestation.
- •2. Birth weight = 500 gr.
- •3. Postnatal age up to 5 days.
- •4. Fraction of inspired oxygen = 0.60 at enrolment.
- •5. The infant is in a cardiovascular stable condition.
- •6. Infant is able to take enteral feed.
- •7. No heart and chest compression or any resuscitation drugs given to the infant during delivery.
- •8. Patient is expected to wean off PN at the primary hospital.
- •9. Informed consent form signed by parents or legal guardian.
- •10. In the Investigator’s opinion, is able to comply with the trial requirements.
- •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
- •1. Complete enteral feeding.
- •2. Major congenital malformation – Infants with genetic, metabolic or endocrine disorder diagnosed before enrolment.
- •3. High index of suspicion of infection before enrolment.
- •4. Intra Uterine Growth Retardation (IUGR) defined as weight for gestational age 5. Confirmed NEC.
- •6. Maternal diabetes (Type I/II or gestational).
- •7. The infant is treated with Insulin.
- •8. NPO, nothing per os for any reason at the study entry.
- •9. Heart and chest compression or any resuscitation drugs given to the infant during delivery.
- •10. Participation in another interventional clinical study that may interfere with the results of this trial.
- •11. In the Investigator’s opinion, is not able to comply with the trial requirements.
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