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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)

29 de julho de 2015 atualizado por: 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.

Visão geral do estudo

Status

Rescindido

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

415

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Alemanha
      • Berlin, Alemanha
        • Swedish Orphan Biovitrum Investigational Site
      • Freiburg, Alemanha
        • Swedish Orphan Biovitrum Investigational Site
      • Heidelberg, Alemanha
        • Swedish Orphan Biovitrum Investigational Site
      • Wiesbaden, Alemanha
        • Swedish Orphan Biovitrum Investigational Site
  • Bélgica
      • Bruges, Bélgica
        • Swedish Orphan Biovitrum Investigational Site
      • Leuven, Bélgica
        • Swedish Orphan Biovitrum Investigational Site
      • Liege, Bélgica
        • Swedish Orphan Biovitrum Investigational Site
      • Rocourt, Bélgica
        • Swedish Orphan Biovitrum Investigational Site
      • Wilrijk, Bélgica
        • Swedish Orphan Biovitrum Investigational Site
  • Espanha
      • Almería, Espanha
        • Swedish Orphan Biovitrum Investigational Site
      • Cádiz, Espanha
        • Swedish Orphan Biovitrum Investigational Site
      • Córdoba, Espanha
        • Swedish Orphan Biovitrum Investigational Site
      • Madrid, Espanha
        • Swedish Orphan Biovitrum Investigational Site
      • Málaga, Espanha
        • Swedish Orphan Biovitrum Investigational Site
      • Oviedo, Espanha
        • Swedish Orphan Biovitrum Investigational Site
      • Salamanca, Espanha
        • Swedish Orphan Biovitrum Investigational Site
      • Santiago de Compostela, Espanha
        • Swedish Orphan Biovitrum Investigational Site
  • Federação Russa
      • Ivanovo, Federação Russa
        • Swedish Orphan Biovitrum Investigational Site
      • Nizhniy Novgorod, Federação Russa
        • Swedish Orphan Biovitrum Investigational Site
  • França
      • Amiens, França
        • Swedish Orphan Biovitrum Investigational Site
      • Lille, França
        • Swedish Orphan Biovitrum Investigational Site
      • Nancy, França
        • Swedish Orphan Biovitrum Investigational Site
      • Paris, França
        • Swedish Orphan Biovitrum Investigational Site
      • Rouen, França
        • Swedish Orphan Biovitrum Investigational Site
      • Strasbourg, França
        • Swedish Orphan Biovitrum Investigational Site
      • Toulouse, França
        • Swedish Orphan Biovitrum Investigational Site
  • Hungria
      • Budapest, Hungria
        • Swedish Orphan Biovitrum Investigational Site
      • Gyula, Hungria
        • Swedish Orphan Biovitrum Investigational Site
      • Miskolc, Hungria
        • Swedish Orphan Biovitrum Investigational Site
      • Nyíregyháza, Hungria
        • Swedish Orphan Biovitrum Investigational Site
      • Pécs, Hungria
        • Swedish Orphan Biovitrum Investigational Site
      • Veszprem, Hungria
        • Swedish Orphan Biovitrum Investigational Site
  • Itália
      • Ancona, Itália
        • Swedish Orphan Biovitrum Investigational Site
      • Bari, Itália
        • Swedish Orphan Biovitrum Investigational Site
      • Foggia, Itália
        • Swedish Orphan Biovitrum Investigational Site
      • Milano, Itália
        • Swedish Orphan Biovitrum Investigational Site
      • Padova, Itália
        • Swedish Orphan Biovitrum Investigational Site
      • Roma, Itália
        • Swedish Orphan Biovitrum Investigational Site
  • Polônia
      • Bydgoszcz, Polônia
        • Swedish Orphan Biovitrum Investigational Site
      • Gdansk, Polônia
        • Swedish Orphan Biovitrum Investigational Site
      • Lodz, Polônia
        • Swedish Orphan Biovitrum Investigational Site
      • Poznan, Polônia
        • Swedish Orphan Biovitrum Investigational Site
      • Warszawa, Polônia
        • Swedish Orphan Biovitrum Investigational Site
  • República Checa
      • Hradec Kralove, República Checa
        • Swedish Orphan Biovitrum Investigational Site
      • Olomouc, República Checa
        • Swedish Orphan Biovitrum Investigational Site
      • Prague, República Checa
        • Swedish Orphan Biovitrum Investigational Site
      • Zlin, República Checa
        • Swedish Orphan Biovitrum Investigational Site
  • Suécia
      • Stockholm, Suécia
        • Swedish Orphan Biovitrum Investigational Site
      • Umeå, Suécia
        • Swedish Orphan Biovitrum Investigational Site

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

Não mais velho que 2 meses (Filho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador de Placebo: Placebo
Medicamento: Placebo
Placebo added to infant formula/pasteurized breast milk during a 4 week treatment period.
Experimental: rhBSSL
rhBSSL (recombinant human bile-salt-stimulated lipase)
Medicamento: rhBSSL (recombinant human bile-salt-stimulated lipase)
rhBSSL added to infant formula/pasteurized breast milk during a 4 week treatment period.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Growth velocity in grams per kilogram per day during 4 weeks of treatment.
Prazo: Baseline and Day 29
Baseline and Day 29

Medidas de resultados secundários

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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Swedish Orphan Biovitrum

Investigadores

  • Diretor de estudo: Kristina Timdahl, MD, Swedish Orphan Biovitrum

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de maio de 2011

Conclusão Primária (Real)

1 de julho de 2013

Conclusão do estudo (Real)

1 de agosto de 2014

Datas de inscrição no estudo

Enviado pela primeira vez

8 de junho de 2011

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de agosto de 2011

Primeira postagem (Estimativa)

10 de agosto de 2011

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

30 de julho de 2015

Última atualização enviada que atendeu aos critérios de controle de qualidade

29 de julho de 2015

Última verificação

1 de julho de 2015

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • BVT.BSSL-030

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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