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Comparison of rhBSSL With Placebo When Added to Infant Formula or Pasteurized Breast Milk During 4 Weeks of Treatment in Preterm Infants (LAIF)

2015年7月29日 更新者：Swedish Orphan Biovitrum

A Prospective, Randomized, Double-Blind, Phase 3 Study Comparing rhBSSL and Placebo Added to Infant Formula or Pasteurized Breast Milk During 4 Weeks of Treatment in Preterm Infants Born Before Week 32 of Gestational Age

The purpose of this study is to demonstrate that rhBSSL improves growth in preterm infants as compared with placebo.

研究概览

地位

终止

条件

干预/治疗

详细说明

The purpose of this study is to demonstrate that rhBSSL improves growth in preterm infants as compared with placebo. The infants should be born before week 32 of gestational age.

The study drug, rhBSSL or placebo, will be administered during a 4 week treatment period by adding it to either infant formula or pasteurized breast milk.

The study will also evaluate the safety and tolerability of rhBSSL.

Eligible patients will be randomized in a ratio of 1:1 (rhBSSL:placebo). The study consists of maximum 1 week screening period, a 4-week treatment period and a 2 year follow-up period.

研究类型

介入性

注册 (实际的)

415

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 俄罗斯联邦
      • Ivanovo、俄罗斯联邦
        • Swedish Orphan Biovitrum Investigational Site
      • Nizhniy Novgorod、俄罗斯联邦
        • Swedish Orphan Biovitrum Investigational Site
  • 匈牙利
      • Budapest、匈牙利
        • Swedish Orphan Biovitrum Investigational Site
      • Gyula、匈牙利
        • Swedish Orphan Biovitrum Investigational Site
      • Miskolc、匈牙利
        • Swedish Orphan Biovitrum Investigational Site
      • Nyíregyháza、匈牙利
        • Swedish Orphan Biovitrum Investigational Site
      • Pécs、匈牙利
        • Swedish Orphan Biovitrum Investigational Site
      • Veszprem、匈牙利
        • Swedish Orphan Biovitrum Investigational Site
  • 德国
      • Berlin、德国
        • Swedish Orphan Biovitrum Investigational Site
      • Freiburg、德国
        • Swedish Orphan Biovitrum Investigational Site
      • Heidelberg、德国
        • Swedish Orphan Biovitrum Investigational Site
      • Wiesbaden、德国
        • Swedish Orphan Biovitrum Investigational Site
  • 意大利
      • Ancona、意大利
        • Swedish Orphan Biovitrum Investigational Site
      • Bari、意大利
        • Swedish Orphan Biovitrum Investigational Site
      • Foggia、意大利
        • Swedish Orphan Biovitrum Investigational Site
      • Milano、意大利
        • Swedish Orphan Biovitrum Investigational Site
      • Padova、意大利
        • Swedish Orphan Biovitrum Investigational Site
      • Roma、意大利
        • Swedish Orphan Biovitrum Investigational Site
  • 捷克共和国
      • Hradec Kralove、捷克共和国
        • Swedish Orphan Biovitrum Investigational Site
      • Olomouc、捷克共和国
        • Swedish Orphan Biovitrum Investigational Site
      • Prague、捷克共和国
        • Swedish Orphan Biovitrum Investigational Site
      • Zlin、捷克共和国
        • Swedish Orphan Biovitrum Investigational Site
  • 比利时
      • Bruges、比利时
        • Swedish Orphan Biovitrum Investigational Site
      • Leuven、比利时
        • Swedish Orphan Biovitrum Investigational Site
      • Liege、比利时
        • Swedish Orphan Biovitrum Investigational Site
      • Rocourt、比利时
        • Swedish Orphan Biovitrum Investigational Site
      • Wilrijk、比利时
        • Swedish Orphan Biovitrum Investigational Site
  • 法国
      • Amiens、法国
        • Swedish Orphan Biovitrum Investigational Site
      • Lille、法国
        • Swedish Orphan Biovitrum Investigational Site
      • Nancy、法国
        • Swedish Orphan Biovitrum Investigational Site
      • Paris、法国
        • Swedish Orphan Biovitrum Investigational Site
      • Rouen、法国
        • Swedish Orphan Biovitrum Investigational Site
      • Strasbourg、法国
        • Swedish Orphan Biovitrum Investigational Site
      • Toulouse、法国
        • Swedish Orphan Biovitrum Investigational Site
  • 波兰
      • Bydgoszcz、波兰
        • Swedish Orphan Biovitrum Investigational Site
      • Gdansk、波兰
        • Swedish Orphan Biovitrum Investigational Site
      • Lodz、波兰
        • Swedish Orphan Biovitrum Investigational Site
      • Poznan、波兰
        • Swedish Orphan Biovitrum Investigational Site
      • Warszawa、波兰
        • Swedish Orphan Biovitrum Investigational Site
  • 瑞典
      • Stockholm、瑞典
        • Swedish Orphan Biovitrum Investigational Site
      • Umeå、瑞典
        • Swedish Orphan Biovitrum Investigational Site
  • 西班牙
      • Almería、西班牙
        • Swedish Orphan Biovitrum Investigational Site
      • Cádiz、西班牙
        • Swedish Orphan Biovitrum Investigational Site
      • Córdoba、西班牙
        • Swedish Orphan Biovitrum Investigational Site
      • Madrid、西班牙
        • Swedish Orphan Biovitrum Investigational Site
      • Málaga、西班牙
        • Swedish Orphan Biovitrum Investigational Site
      • Oviedo、西班牙
        • Swedish Orphan Biovitrum Investigational Site
      • Salamanca、西班牙
        • Swedish Orphan Biovitrum Investigational Site
      • Santiago de Compostela、西班牙
        • Swedish Orphan Biovitrum Investigational Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

不超过 2个月 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Preterm infants born before week 32 of gestation.
  • Preterm infant who is less than 33 weeks postmenstrual age at the time of randomization.
  • Preterm infant who is appropriate for gestational age (AGA) or small for gestational age (SGA) at birth.
  • Preterm infant who is receiving food enterally (bottle or gavage tube) at a level of at least 100 ml/kg/day at randomization.
  • Preterm infant whose enteral feeding consists of only infant formula or only pasteurized breast milk at the time of inclusion, and who are expected to remain on only infant formula for 4 weeks, or only pasteurized breast milk for at least 2 weeks following treatment initiation.
  • Preterm infant who is expected not to receive any fresh breast milk for 4 weeks following treatment initiation.
  • Informed consent is obtained.

Exclusion Criteria:

  • Expected stay in the hospital is less than 4 weeks from the first dose of study drug.
  • Criteria to ensure no disease or treatment affecting growth or development, e.g. brain disease, necrotizing enterocolitis.
  • Enrolled in another concurrent clinical intervention study.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：安慰剂
药品：Placebo
Placebo added to infant formula/pasteurized breast milk during a 4 week treatment period.
实验性的：rhBSSL
rhBSSL (recombinant human bile-salt-stimulated lipase)
药品：rhBSSL (recombinant human bile-salt-stimulated lipase)
rhBSSL added to infant formula/pasteurized breast milk during a 4 week treatment period.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Growth velocity in grams per kilogram per day during 4 weeks of treatment.
大体时间：Baseline and Day 29
Baseline and Day 29

次要结果测量

结果测量
措施说明
大体时间
Change from baseline in body weight (g) at 3 months
大体时间：Baseline and Month 3
Baseline and Month 3
Body weight (g) at 12 months' corrected age
大体时间：12 months´ corrected age
12 months´ corrected age
Body weight (g) at 24 months' corrected age
大体时间：24 months´ corrected age
24 months´ corrected age
Change from baseline in total body length (mm) at 4 weeks
大体时间：Baseline and Day 29
Baseline and Day 29
Change from baseline in total body length (mm) at 3 months
大体时间：Baseline and Month 3
Baseline and Month 3
Total body length (mm) at 12 months' corrected age
大体时间：12 months' corrected age
12 months' corrected age
Total body height (cm) at 24 months' corrected age
大体时间：24 months' corrected age
24 months' corrected age
Growth restriction
大体时间：Day 29
Defined as growth velocity <15 gram per kilogram bodyweight per day during 4 weeks of treatment
Day 29
Time to readiness for discharge
大体时间：Baseline and date of readiness for discharge

Time until each of the following are fulfilled

  • sustained weight gain (weight of 1800 g sustained for three days)
  • ability to maintain normal body temperature
  • ability to suckle feed
  • ability to maintain stable cardiorespiratory function
Baseline and date of readiness for discharge
Time to discharge
大体时间：Baseline and date of discharge
Baseline and date of discharge
Change from baseline in head circumference (mm) at 4 weeks.
大体时间：Baseline and Day 29
Baseline and Day 29
Change from baseline in head circumference (mm) at 3 months.
大体时间：Baseline and Month 3
Baseline and Month 3
Head circumference (mm) at 12 months' corrected age.
大体时间：12 months´ corrected age
12 months´ corrected age
Head circumference (mm) at 24 months' corrected age.
大体时间：24 months´ corrected age
24 months´ corrected age
Time from baseline to 150 mL/kg/day of enteral feeding
大体时间：Date of first dose and date 150 mL/kg/day of enteral feeding achieved (or exceeded)
Date of first dose and date 150 mL/kg/day of enteral feeding achieved (or exceeded)
Re-admission to hospital within 1 month of discharge
大体时间：Date of discharge and date of re-admission
Date of discharge and date of re-admission
Bayley Scale of Infant and Toddler Development, third edition: Cognitive domain composite score 12 months' corrected age
大体时间：12 months' corrected age
12 months' corrected age
Bayley Scale of Infant and Toddler Development, third edition: Cognitive domain composite score at 24 months' corrected age
大体时间：24 months' corrected age
24 months' corrected age
Bayley Scale of Infant and Toddler Development, third edition: Language domain composite score at 12 months' corrected age
大体时间：12 months' corrected age
12 months' corrected age
Bayley Scale of Infant and Toddler Development, third edition: Language domain composite score at 24 months' corrected age
大体时间：24 months' corrected age
24 months' corrected age
Bayley Scale of Infant and Toddler Development, third edition: Motor domain composite score at 12 months' corrected age
大体时间：12 months' corrected age
12 months' corrected age
Bayley Scale of Infant and Toddler Development, third edition: Motor domain composite score at 24 months' corrected age
大体时间：24 months' corrected age
24 months' corrected age
Bayley Scale of Infant and Toddler Development, third edition: Social-emotional domain composite score at 24 months' corrected age
大体时间：24 months' corrected age
24 months' corrected age
Bayley Scale of Infant and Toddler Development, third edition: Adaptive behavior domain composite score at 24 months' corrected age
大体时间：24 months' corrected age
24 months' corrected age
Neurodevelopment Disability Composite
大体时间：24 months' corrected age

Presence of :

  • Composite score of less than 70 on any of the cognitive, language or motor domains of Bayley scale of infant and toddler development, third edition
  • Bilateral deafness
  • Bilateral blindness
  • Cerebral palsy
24 months' corrected age
Child Behavior Checklist total problem score at 24 months' corrected age
大体时间：24 months' corrected age visit
24 months' corrected age visit
Number of patients with at least one treatment emergent Adverse Event
大体时间：Baseline and Day 29
Total and by system organ class and preferred term (coded by MedDRA)
Baseline and Day 29
Number of patients with at least one treatment emergent Adverse Event
大体时间：Day 29 and Month 3
Total and by system organ class and preferred term (coded by MedDRA)
Day 29 and Month 3
Number of patients with at least one treatment emergent Serious Adverse Event
大体时间：Baseline and Day 29
Total and by system organ class and preferred term (coded by MedDRA)
Baseline and Day 29
Number of patients with at least one treatment emergent Serious Adverse Event
大体时间：Day 29 and Month 3
Total and by system organ class and preferred term (coded by MedDRA)
Day 29 and Month 3
Number of patients with at least one Serious Adverse Drug Reaction
大体时间：12 months' corrected age and 24 months' corrected age
Total and by system organ class and preferred term (coded by MedDRA)
12 months' corrected age and 24 months' corrected age
Level of Vitamin A (nmol/L) at 4 weeks
大体时间：Day 29
Day 29
Level of Vitamin D (nmol/L) at 4 weeks
大体时间：Day 29
Day 29
Number of outpatient visits from the time of initial hospital discharge to home up to 24 months' corrected age
大体时间：Date of initial hospital discharge to home to date of 24 months' corrected age
Date of initial hospital discharge to home to date of 24 months' corrected age
Number of inpatient visits from the time of initial hospital discharge to home up to 24 months' corrected age
大体时间：Date of initial hospital discharge to home to date of 24 months' corrected age
Date of initial hospital discharge to home to date of 24 months' corrected age
Number of days of hospitalization from the time of initial hospital discharge to home up to 24 months' corrected age
大体时间：Date of initial hospital discharge to home to date of 24 months' corrected age
Date of initial hospital discharge to home to date of 24 months' corrected age
Number of days in intensive care unit from the time of initial hospital discharge to home up to 24 months' corrected age
大体时间：Date of initial hospital discharge to home to date of 24 months' corrected age
Date of initial hospital discharge to home to date of 24 months' corrected age
Number of days lost from work related to the child's condition from the time of initial hospital discharge to home up to 24 months' corrected age
大体时间：Date of initial hospital discharge to home to date of 24 months' corrected age
Date of initial hospital discharge to home to date of 24 months' corrected age
Presence of chronic medical conditions/diagnoses at 24 months' corrected age
大体时间：24 months' corrected age
24 months' corrected age
Docosahexaenoic acid (% of total fatty acids) in the serum triglyceride fraction at 4 weeks
大体时间：Day 29
Day 29
Docosahexaenoic acid (% of total fatty acids) in the serum phosphatidylcholine fraction at 4 weeks
大体时间：Day 29
Day 29
Arachidonic acid (% of total fatty acids) in the serum triglyceride fraction at 4 weeks
大体时间：Day 29
Day 29
Arachidonic acid (% of total fatty acids) in the serum phosphatidylcholine fraction at 4 weeks
大体时间：Day 29
Day 29
Number of patients with antibodies to rhBSSL at 4 weeks
大体时间：Day 29
Day 29
Number of patients with antibodies to rhBSSL at Month 3
大体时间：Month 3
Month 3
Number of patients with antibodies to rhBSSL at 12 months' corrected age
大体时间：12 months' corrected age
12 months' corrected age

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Swedish Orphan Biovitrum

调查人员

  • 研究主任：Kristina Timdahl, MD、Swedish Orphan Biovitrum

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年5月1日

初级完成 (实际的)

2013年7月1日

研究完成 (实际的)

2014年8月1日

研究注册日期

首次提交

2011年6月8日

首先提交符合 QC 标准的

2011年8月9日

首次发布 (估计)

2011年8月10日

研究记录更新

最后更新发布 (估计)

2015年7月30日

上次提交的符合 QC 标准的更新

2015年7月29日

最后验证

2015年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • BVT.BSSL-030

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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