NL-OMON53321尚未招募2 期
A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Basket Study to Assess the Safety of ELGN-2112 in Populations of Interest - FIT-05
ELGAN Pharma0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
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
- 年龄范围
- 0 至 0（—）
入选标准
- •1. Male or female preterm infant born less than 26 weeks GA (up to 25+6) or
- •Intra-Uterine Growth Restricted (IUGR) infants (below 3rd percentile), born
- •between 26+0 to 31+6 GA. *Gestational age matching (±2 weeks) between maternal
- •dates and/or early antenatal ultrasound. 2. Birth weight >= 450g 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 feeds 8. Infant is expected to wean off
- •parenteral nutrition (PN) at the primary hospital 9. Informed consent form
- •signed by parents or legal guardian 10. In the Investigator*s opinion, the
- •infant is sufficiently stable to partake in the trial to completion * If both
- •exist and difference > 2 weeks, based on early antenatal ultrasound
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. For infants born under 26 weeks GA, Intra-uterine growth restriction (IUGR)
- •defined as weight for gestational age less than the third percentile according
- •to Fenton preterm growth chart.
- •5. Confirmed necrotizing enterocolitis (NEC)
- •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
- •10. 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
研究者
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