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. - A Study to Assess the Efficacy and Safety of 2 dose levels of NTRA-2112 in Preterm Infants

utrinia Ltd.0 个研究点目标入组 530 人开始时间: 2015年12月15日最近更新: 2019年2月28日

研究概览

暂无简介。

•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

•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**
•4.Intra-uterine growth retardation (IUGR) defined as either weight for gestational age less than the third percentile or less than the 10’th percentile with Doppler abnormalities in utero***.
•5.Confirmed necrotizing enterocolitis (NEC).
•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
•**Defined as positive blood culture, Leukocytosis >30,000 and Leukopenia <4,000.
•***According to Fenton preterm growth chart (see Appendix D). If no Doppler in utero is available for infants with IUGR between third and 10’th percentile of Fenton preterm growth charts, infant is eligible to participate in the study.

发起方

utrinia Ltd.