EUCTR2014-002624-28-HU进行中（未招募）1 期
A Multi-center, Double-blind, Randomized, Three-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants - FIT-04 V7.0
utrinia Ltd.0 个研究点目标入组 530 人开始时间: 2017年8月2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
- 530
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. Male or female pre-term infants 26 and up to 32 weeks gestation (32 weeks + 0 day maximum). Gestational age matching (±2 weeks) between maternal dates and/or early antenatal ultrasound*.
- •2. Birth weight = 500g.
- •3. Singleton, or twin birth.
- •4. Postnatal age up through and including Day 5 (up to 120 hours post birth).
- •5. Fraction of inspired oxygen = 0.60 at enrolment.
- •6. Subjects must demonstrate cardiovascular stability at time of enrolment and would be considered unstable if they require >40% oxygen with blood pressure support and the need for umbilical artery cauterization.
- •7. Infant is able to tolerate enteral feed.
- •8. Infant is expected to wean off PN at the primary hospital.
- •9. Informed consent form (ICF) signed by parents or legal guardian.
- •10. In the Investigator’s opinion, the infant is able to comply with the study procedures and sufficiently stable to partake in the trial as required until trial completion.
- •* If both exist and difference > 2 weeks, based on early antenatal ultrasound
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 530
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Complete enteral feeding.
- •2. Major congenital malformation (e.g., Infants with genetic, metabolic, and/or endocrine disorder diagnosed before enrolment).
- •3. High index of suspicion of infection before enrolment-
- •Defined as positive blood culture, Leukocytosis >30,000 and Leukopenia <4,000.
- •4. Intra-uterine growth retardation (IUGR) defined as either weight for gestational age less than the third percentile or less than the 10th percentile with Doppler abnormalities in utero. According to Fenton preterm growth chart (see Appendix D). If no in utero Doppler study is available for infants with IUGR between third and 10’th percentile of Fenton preterm growth charts, the infant will be eligible to participate in the study.
- •5. Confirmed necrotizing enterocolitis (NEC).NEC is characterized by the sudden onset of gastrointestinal distress that may include symptoms such as vomiting, abdominal distention, bloody stools, or dilated loops of bowel that leads to cessation of enteral feedings.
- •6. Maternal diabetes (Type I/II or gestational) requiring insulin during pregnancy or in mothers past medical history.
- •7. Hyperinsulinemia requiring glucose administration of more than 12mg/kg/min at randomization.
- •8. Any systemic insulin administration at randomization.
- •9. Nothing per os (NPO) for any reason at the study entry.
- •10. Heart and chest compression or any resuscitation drugs given to the infant during delivery.
- •11. Subjects at risk for significant GI complications such as twin-to-twin transfusion syndrome (TTTS) or monochorionic monoamniotic twins.
- •12. Participation in another interventional clinical study that may interfere with the results of this trial
研究者
相似试验
进行中（未招募）
1 期
A Multi-center, Double-blind, Randomized, Three-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm InfantsIntestinal malabsorption in pre-term infantsEUCTR2014-002624-28-GButrinia Ltd.530
进行中（未招募）
1 期
A Multi-center, Double-blind, Randomized, Three-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm InfantsEUCTR2014-002624-28-BGutrinia Ltd.530
进行中（未招募）
1 期
To assess the efficacy of 2 doses of NTRA-2112 as compared to placebo on intestinal malabsorption in preterm infants as measured by the time to full enteral feeding.EUCTR2014-002624-28-NLutrinia Ltd.530
进行中（未招募）
1 期
To assess the efficacy and safety of 2 doses of NTRA-2112 as compared to placebo on intestinal malabsorption in preterm infants as measured by the time to reach full enteral feeding.EUCTR2014-002624-28-DEutrinia Ltd.530
已完成
3 期
A Multi-center, Double-blind, Randomized, Three-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants.prematuratieintestinal malabsorption in preterm infants10025477NL-OMON46903utrinia Ltd200