Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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 julio de 2015 actualizado 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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 estudio

Intervencionista

Inscripción (Actual)

415

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Berlin, Alemania
        • Swedish Orphan Biovitrum Investigational Site
      • Freiburg, Alemania
        • Swedish Orphan Biovitrum Investigational Site
      • Heidelberg, Alemania
        • Swedish Orphan Biovitrum Investigational Site
      • Wiesbaden, Alemania
        • 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
  • España
      • Almería, España
        • Swedish Orphan Biovitrum Investigational Site
      • Cádiz, España
        • Swedish Orphan Biovitrum Investigational Site
      • Córdoba, España
        • Swedish Orphan Biovitrum Investigational Site
      • Madrid, España
        • Swedish Orphan Biovitrum Investigational Site
      • Málaga, España
        • Swedish Orphan Biovitrum Investigational Site
      • Oviedo, España
        • Swedish Orphan Biovitrum Investigational Site
      • Salamanca, España
        • Swedish Orphan Biovitrum Investigational Site
      • Santiago de Compostela, España
        • Swedish Orphan Biovitrum Investigational Site
  • Federación Rusa
      • Ivanovo, Federación Rusa
        • Swedish Orphan Biovitrum Investigational Site
      • Nizhniy Novgorod, Federación Rusa
        • Swedish Orphan Biovitrum Investigational Site
  • Francia
      • Amiens, Francia
        • Swedish Orphan Biovitrum Investigational Site
      • Lille, Francia
        • Swedish Orphan Biovitrum Investigational Site
      • Nancy, Francia
        • Swedish Orphan Biovitrum Investigational Site
      • Paris, Francia
        • Swedish Orphan Biovitrum Investigational Site
      • Rouen, Francia
        • Swedish Orphan Biovitrum Investigational Site
      • Strasbourg, Francia
        • Swedish Orphan Biovitrum Investigational Site
      • Toulouse, Francia
        • Swedish Orphan Biovitrum Investigational Site
  • Hungría
      • Budapest, Hungría
        • Swedish Orphan Biovitrum Investigational Site
      • Gyula, Hungría
        • Swedish Orphan Biovitrum Investigational Site
      • Miskolc, Hungría
        • Swedish Orphan Biovitrum Investigational Site
      • Nyíregyháza, Hungría
        • Swedish Orphan Biovitrum Investigational Site
      • Pécs, Hungría
        • Swedish Orphan Biovitrum Investigational Site
      • Veszprem, Hungría
        • Swedish Orphan Biovitrum Investigational Site
  • Italia
      • Ancona, Italia
        • Swedish Orphan Biovitrum Investigational Site
      • Bari, Italia
        • Swedish Orphan Biovitrum Investigational Site
      • Foggia, Italia
        • Swedish Orphan Biovitrum Investigational Site
      • Milano, Italia
        • Swedish Orphan Biovitrum Investigational Site
      • Padova, Italia
        • Swedish Orphan Biovitrum Investigational Site
      • Roma, Italia
        • Swedish Orphan Biovitrum Investigational Site
  • Polonia
      • Bydgoszcz, Polonia
        • Swedish Orphan Biovitrum Investigational Site
      • Gdansk, Polonia
        • Swedish Orphan Biovitrum Investigational Site
      • Lodz, Polonia
        • Swedish Orphan Biovitrum Investigational Site
      • Poznan, Polonia
        • Swedish Orphan Biovitrum Investigational Site
      • Warszawa, Polonia
        • 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
  • Suecia
      • Stockholm, Suecia
        • Swedish Orphan Biovitrum Investigational Site
      • Umeå, Suecia
        • Swedish Orphan Biovitrum Investigational Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

No mayor que 2 meses (Niño)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: Placebo
Droga: Placebo
Placebo added to infant formula/pasteurized breast milk during a 4 week treatment period.
Experimental: rhBSSL
rhBSSL (recombinant human bile-salt-stimulated lipase)
Droga: rhBSSL (recombinant human bile-salt-stimulated lipase)
rhBSSL added to infant formula/pasteurized breast milk during a 4 week treatment period.

¿Qué mide el estudio?

Medidas de resultado primarias

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

Medidas de resultado secundarias

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Swedish Orphan Biovitrum

Investigadores

  • Director de estudio: Kristina Timdahl, MD, Swedish Orphan Biovitrum

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de mayo de 2011

Finalización primaria (Actual)

1 de julio de 2013

Finalización del estudio (Actual)

1 de agosto de 2014

Fechas de registro del estudio

Enviado por primera vez

8 de junio de 2011

Primero enviado que cumplió con los criterios de control de calidad

9 de agosto de 2011

Publicado por primera vez (Estimar)

10 de agosto de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

30 de julio de 2015

Última actualización enviada que cumplió con los criterios de control de calidad

29 de julio de 2015

Última verificación

1 de julio de 2015

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • BVT.BSSL-030

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Buscar ensayos similares

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

CROs by country

CROs in Greece

Condiciones

Enfermedades Raras

Intervenciones de drogas

Suplementos dietéticos

Patrocinador / Colaboradores

Localizaciones

Suscribir