A Randomized, Controlled Study to Assess Growth and Safety of the Exclusive Human Milk Diet (EHMD) in Very Low Birth Weight (VLBW) Infants (<1,500 g)

Kato Yoshio0 个研究点目标入组 146 人开始时间: 2021年10月20日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1.VLBW infants (<1,500 g) born before 31 weeks 0 days gestational age
•2.Within the first 10 days of life (day 0-10)
•3.Diet consisted of 100% exclusive HM (MOM or DM) or NPO prior to study enrollment
•4.Willing to follow the study diet and adhere to study procedures per the legal guardian
•5.Written informed consent from the legal guardian of the infant
•6.Informed consent obtained prior to reaching 50 ml/kg/day because this is when fortification begins

•1.Lethal or otherwise significant congenital abnormalities known at the time of inclusion 2.Chromosomal anomalies known at the time of inclusion 3.Known gastrointestinal malformation at the time of inclusion 4.Participation in another intervention trial aiming at having an effect on growth, nutrition, feeding intolerance, or severe complications such as NEC and sepsis in VLBW infants,
•however it is permissible to participate in the interventional clinical trial of DM that is currently being run in Japan in parallel with this trial. 5.The subject is unable to start enteral feeding within the first 3 days of life and parenteral feeding within the first 2 days of life 6.Infants who, for medical reasons, cannot receive a feeding volume of at least 130 ml/kg/day 7.In the opinion of the investigator, the subject is incapable of receiving IMP and standard nutritional management. This may be due to very intensive respiratory support, medication needed to assist blood pressure, or need for multiple episodes of cardiopulmonary resuscitation on Days 1-2 of life, among others. 8. Those who have a history of hypersensitivity to the components of this drug. 9. Infant who develops NEC or sepsis prior to randomization must be excluded from the study.

发起方

Kato Yoshio