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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)

2015년 7월 29일 업데이트: 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.

연구 개요

상태

종료됨

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

415

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 독일
      • Berlin, 독일
        • Swedish Orphan Biovitrum Investigational Site
      • Freiburg, 독일
        • Swedish Orphan Biovitrum Investigational Site
      • Heidelberg, 독일
        • Swedish Orphan Biovitrum Investigational Site
      • Wiesbaden, 독일
        • Swedish Orphan Biovitrum Investigational Site
  • 러시아 연방
      • Ivanovo, 러시아 연방
        • Swedish Orphan Biovitrum Investigational Site
      • Nizhniy Novgorod, 러시아 연방
        • Swedish Orphan Biovitrum Investigational Site
  • 벨기에
      • Bruges, 벨기에
        • Swedish Orphan Biovitrum Investigational Site
      • Leuven, 벨기에
        • Swedish Orphan Biovitrum Investigational Site
      • Liege, 벨기에
        • Swedish Orphan Biovitrum Investigational Site
      • Rocourt, 벨기에
        • Swedish Orphan Biovitrum Investigational Site
      • Wilrijk, 벨기에
        • Swedish Orphan Biovitrum Investigational Site
  • 스웨덴
      • Stockholm, 스웨덴
        • Swedish Orphan Biovitrum Investigational Site
      • Umeå, 스웨덴
        • Swedish Orphan Biovitrum Investigational Site
  • 스페인
      • Almería, 스페인
        • Swedish Orphan Biovitrum Investigational Site
      • Cádiz, 스페인
        • Swedish Orphan Biovitrum Investigational Site
      • Córdoba, 스페인
        • Swedish Orphan Biovitrum Investigational Site
      • Madrid, 스페인
        • Swedish Orphan Biovitrum Investigational Site
      • Málaga, 스페인
        • Swedish Orphan Biovitrum Investigational Site
      • Oviedo, 스페인
        • Swedish Orphan Biovitrum Investigational Site
      • Salamanca, 스페인
        • Swedish Orphan Biovitrum Investigational Site
      • Santiago de Compostela, 스페인
        • Swedish Orphan Biovitrum Investigational Site
  • 이탈리아
      • Ancona, 이탈리아
        • Swedish Orphan Biovitrum Investigational Site
      • Bari, 이탈리아
        • Swedish Orphan Biovitrum Investigational Site
      • Foggia, 이탈리아
        • Swedish Orphan Biovitrum Investigational Site
      • Milano, 이탈리아
        • Swedish Orphan Biovitrum Investigational Site
      • Padova, 이탈리아
        • Swedish Orphan Biovitrum Investigational Site
      • Roma, 이탈리아
        • Swedish Orphan Biovitrum Investigational Site
  • 체코 공화국
      • Hradec Kralove, 체코 공화국
        • Swedish Orphan Biovitrum Investigational Site
      • Olomouc, 체코 공화국
        • Swedish Orphan Biovitrum Investigational Site
      • Prague, 체코 공화국
        • Swedish Orphan Biovitrum Investigational Site
      • Zlin, 체코 공화국
        • Swedish Orphan Biovitrum Investigational Site
  • 폴란드
      • Bydgoszcz, 폴란드
        • Swedish Orphan Biovitrum Investigational Site
      • Gdansk, 폴란드
        • Swedish Orphan Biovitrum Investigational Site
      • Lodz, 폴란드
        • Swedish Orphan Biovitrum Investigational Site
      • Poznan, 폴란드
        • Swedish Orphan Biovitrum Investigational Site
      • Warszawa, 폴란드
        • Swedish Orphan Biovitrum Investigational Site
  • 프랑스
      • Amiens, 프랑스
        • Swedish Orphan Biovitrum Investigational Site
      • Lille, 프랑스
        • Swedish Orphan Biovitrum Investigational Site
      • Nancy, 프랑스
        • Swedish Orphan Biovitrum Investigational Site
      • Paris, 프랑스
        • Swedish Orphan Biovitrum Investigational Site
      • Rouen, 프랑스
        • Swedish Orphan Biovitrum Investigational Site
      • Strasbourg, 프랑스
        • Swedish Orphan Biovitrum Investigational Site
      • Toulouse, 프랑스
        • Swedish Orphan Biovitrum Investigational Site
  • 헝가리
      • Budapest, 헝가리
        • Swedish Orphan Biovitrum Investigational Site
      • Gyula, 헝가리
        • Swedish Orphan Biovitrum Investigational Site
      • Miskolc, 헝가리
        • Swedish Orphan Biovitrum Investigational Site
      • Nyíregyháza, 헝가리
        • Swedish Orphan Biovitrum Investigational Site
      • Pécs, 헝가리
        • Swedish Orphan Biovitrum Investigational Site
      • Veszprem, 헝가리
        • Swedish Orphan Biovitrum Investigational Site

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

2개월 이하 (어린이)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: 위약
의약품: Placebo
Placebo added to infant formula/pasteurized breast milk during a 4 week treatment period.
실험적: rhBSSL
rhBSSL (recombinant human bile-salt-stimulated lipase)
의약품: rhBSSL (recombinant human bile-salt-stimulated lipase)
rhBSSL added to infant formula/pasteurized breast milk during a 4 week treatment period.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Growth velocity in grams per kilogram per day during 4 weeks of treatment.
기간: Baseline and Day 29
Baseline and Day 29

2차 결과 측정

결과 측정
측정값 설명
기간
Change from baseline in body weight (g) at 3 months
기간: Baseline and Month 3
Baseline and Month 3
Body weight (g) at 12 months' corrected age
기간: 12 months´ corrected age
12 months´ corrected age
Body weight (g) at 24 months' corrected age
기간: 24 months´ corrected age
24 months´ corrected age
Change from baseline in total body length (mm) at 4 weeks
기간: Baseline and Day 29
Baseline and Day 29
Change from baseline in total body length (mm) at 3 months
기간: Baseline and Month 3
Baseline and Month 3
Total body length (mm) at 12 months' corrected age
기간: 12 months' corrected age
12 months' corrected age
Total body height (cm) at 24 months' corrected age
기간: 24 months' corrected age
24 months' corrected age
Growth restriction
기간: 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
기간: 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
기간: Baseline and date of discharge
Baseline and date of discharge
Change from baseline in head circumference (mm) at 4 weeks.
기간: Baseline and Day 29
Baseline and Day 29
Change from baseline in head circumference (mm) at 3 months.
기간: Baseline and Month 3
Baseline and Month 3
Head circumference (mm) at 12 months' corrected age.
기간: 12 months´ corrected age
12 months´ corrected age
Head circumference (mm) at 24 months' corrected age.
기간: 24 months´ corrected age
24 months´ corrected age
Time from baseline to 150 mL/kg/day of enteral feeding
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 24 months' corrected age
24 months' corrected age
Neurodevelopment Disability Composite
기간: 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
기간: 24 months' corrected age visit
24 months' corrected age visit
Number of patients with at least one treatment emergent Adverse Event
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Day 29
Day 29
Level of Vitamin D (nmol/L) at 4 weeks
기간: Day 29
Day 29
Number of outpatient visits from the time of initial hospital discharge to home up to 24 months' corrected age
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 24 months' corrected age
24 months' corrected age
Docosahexaenoic acid (% of total fatty acids) in the serum triglyceride fraction at 4 weeks
기간: Day 29
Day 29
Docosahexaenoic acid (% of total fatty acids) in the serum phosphatidylcholine fraction at 4 weeks
기간: Day 29
Day 29
Arachidonic acid (% of total fatty acids) in the serum triglyceride fraction at 4 weeks
기간: Day 29
Day 29
Arachidonic acid (% of total fatty acids) in the serum phosphatidylcholine fraction at 4 weeks
기간: Day 29
Day 29
Number of patients with antibodies to rhBSSL at 4 weeks
기간: Day 29
Day 29
Number of patients with antibodies to rhBSSL at Month 3
기간: Month 3
Month 3
Number of patients with antibodies to rhBSSL at 12 months' corrected age
기간: 12 months' corrected age
12 months' corrected age

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Swedish Orphan Biovitrum

수사관

  • 연구 책임자: Kristina Timdahl, MD, Swedish Orphan Biovitrum

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2011년 5월 1일

기본 완료 (실제)

2013년 7월 1일

연구 완료 (실제)

2014년 8월 1일

연구 등록 날짜

최초 제출

2011년 6월 8일

QC 기준을 충족하는 최초 제출

2011년 8월 9일

처음 게시됨 (추정)

2011년 8월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 7월 30일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 7월 29일

마지막으로 확인됨

2015년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • BVT.BSSL-030

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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약물 개입

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스폰서 / 협력자

위치

구독하다