EUCTR2021-004890-29-SE进行中（未招募）1 期
A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants - FIT-PIV
ELGAN Pharma0 个研究点目标入组 360 人开始时间: 2022年10月3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
- 360
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
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. Infants must demonstrate cardiovascular stability at time of enrolment and would be considered unstable if they require blood pressure support via a central line.
- •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 sufficiently stable to partake in the trial to completion .
- •11. (France only) - only participants benefiting from a health insurance plan can participate in research .
- •* 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: 360
- •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. Infant is consuming more than 100 ml/kg/day enterally at study entry
- •2. Infant is not dependent on any parenteral amino acids/lipids as nutrition
- •3. Major congenital malformation (e.g., Infants with genetic, metabolic, and/or endocrine disorder diagnosed before enrolment).
- •4. Intra-uterine growth restriction (IUGR) defined as weight for gestational age less than the third percentile according to Fenton preterm growth chart (see Appendix D).
- •5. Confirmed necrotizing enterocolitis (NEC).1
- •6. Maternal diabetes (Type I/II or gestational) requiring insulin during pregnancy or in mothers past medical history.
- •7. suspected or confirmed Hyperinsulinemia requiring glucose administration of more than 12 mg/kg/min at randomization.
- •8. Any systemic insulin administration at randomization.
- •9. Nothing per os (NPO) at study entry and enteral/oral supplements are not allowed
- •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. **
- •13.Hypersensitivity to any of the drug components- Recombinant Human Insulin (rh-Insulin), Maltodextrin, Sodium Chloride
- •** Participation in another interventional clinical study that may interfere with the results of this trial is not allowed until discharge from the hospital
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