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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 juillet 2015 mis à jour par: 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.

Aperçu de l'étude

Statut

Résilié

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

415

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Allemagne
      • Berlin, Allemagne
        • Swedish Orphan Biovitrum Investigational Site
      • Freiburg, Allemagne
        • Swedish Orphan Biovitrum Investigational Site
      • Heidelberg, Allemagne
        • Swedish Orphan Biovitrum Investigational Site
      • Wiesbaden, Allemagne
        • Swedish Orphan Biovitrum Investigational Site
  • Belgique
      • Bruges, Belgique
        • Swedish Orphan Biovitrum Investigational Site
      • Leuven, Belgique
        • Swedish Orphan Biovitrum Investigational Site
      • Liege, Belgique
        • Swedish Orphan Biovitrum Investigational Site
      • Rocourt, Belgique
        • Swedish Orphan Biovitrum Investigational Site
      • Wilrijk, Belgique
        • Swedish Orphan Biovitrum Investigational Site
  • Espagne
      • Almería, Espagne
        • Swedish Orphan Biovitrum Investigational Site
      • Cádiz, Espagne
        • Swedish Orphan Biovitrum Investigational Site
      • Córdoba, Espagne
        • Swedish Orphan Biovitrum Investigational Site
      • Madrid, Espagne
        • Swedish Orphan Biovitrum Investigational Site
      • Málaga, Espagne
        • Swedish Orphan Biovitrum Investigational Site
      • Oviedo, Espagne
        • Swedish Orphan Biovitrum Investigational Site
      • Salamanca, Espagne
        • Swedish Orphan Biovitrum Investigational Site
      • Santiago de Compostela, Espagne
        • Swedish Orphan Biovitrum Investigational Site
  • France
      • Amiens, France
        • Swedish Orphan Biovitrum Investigational Site
      • Lille, France
        • Swedish Orphan Biovitrum Investigational Site
      • Nancy, France
        • Swedish Orphan Biovitrum Investigational Site
      • Paris, France
        • Swedish Orphan Biovitrum Investigational Site
      • Rouen, France
        • Swedish Orphan Biovitrum Investigational Site
      • Strasbourg, France
        • Swedish Orphan Biovitrum Investigational Site
      • Toulouse, France
        • Swedish Orphan Biovitrum Investigational Site
  • Fédération Russe
      • Ivanovo, Fédération Russe
        • Swedish Orphan Biovitrum Investigational Site
      • Nizhniy Novgorod, Fédération Russe
        • Swedish Orphan Biovitrum Investigational Site
  • Hongrie
      • Budapest, Hongrie
        • Swedish Orphan Biovitrum Investigational Site
      • Gyula, Hongrie
        • Swedish Orphan Biovitrum Investigational Site
      • Miskolc, Hongrie
        • Swedish Orphan Biovitrum Investigational Site
      • Nyíregyháza, Hongrie
        • Swedish Orphan Biovitrum Investigational Site
      • Pécs, Hongrie
        • Swedish Orphan Biovitrum Investigational Site
      • Veszprem, Hongrie
        • Swedish Orphan Biovitrum Investigational Site
  • Italie
      • Ancona, Italie
        • Swedish Orphan Biovitrum Investigational Site
      • Bari, Italie
        • Swedish Orphan Biovitrum Investigational Site
      • Foggia, Italie
        • Swedish Orphan Biovitrum Investigational Site
      • Milano, Italie
        • Swedish Orphan Biovitrum Investigational Site
      • Padova, Italie
        • Swedish Orphan Biovitrum Investigational Site
      • Roma, Italie
        • Swedish Orphan Biovitrum Investigational Site
  • Pologne
      • Bydgoszcz, Pologne
        • Swedish Orphan Biovitrum Investigational Site
      • Gdansk, Pologne
        • Swedish Orphan Biovitrum Investigational Site
      • Lodz, Pologne
        • Swedish Orphan Biovitrum Investigational Site
      • Poznan, Pologne
        • Swedish Orphan Biovitrum Investigational Site
      • Warszawa, Pologne
        • Swedish Orphan Biovitrum Investigational Site
  • République tchèque
      • Hradec Kralove, République tchèque
        • Swedish Orphan Biovitrum Investigational Site
      • Olomouc, République tchèque
        • Swedish Orphan Biovitrum Investigational Site
      • Prague, République tchèque
        • Swedish Orphan Biovitrum Investigational Site
      • Zlin, République tchèque
        • Swedish Orphan Biovitrum Investigational Site
  • Suède
      • Stockholm, Suède
        • Swedish Orphan Biovitrum Investigational Site
      • Umeå, Suède
        • Swedish Orphan Biovitrum Investigational Site

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Pas plus vieux que 2 mois (Enfant)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur placebo: Placebo
Médicament: Placebo
Placebo added to infant formula/pasteurized breast milk during a 4 week treatment period.
Expérimental: rhBSSL
rhBSSL (recombinant human bile-salt-stimulated lipase)
Médicament: rhBSSL (recombinant human bile-salt-stimulated lipase)
rhBSSL added to infant formula/pasteurized breast milk during a 4 week treatment period.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Growth velocity in grams per kilogram per day during 4 weeks of treatment.
Délai: Baseline and Day 29
Baseline and Day 29

Mesures de résultats secondaires

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Swedish Orphan Biovitrum

Les enquêteurs

  • Directeur d'études: Kristina Timdahl, MD, Swedish Orphan Biovitrum

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mai 2011

Achèvement primaire (Réel)

1 juillet 2013

Achèvement de l'étude (Réel)

1 août 2014

Dates d'inscription aux études

Première soumission

8 juin 2011

Première soumission répondant aux critères de contrôle qualité

9 août 2011

Première publication (Estimation)

10 août 2011

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

30 juillet 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 juillet 2015

Dernière vérification

1 juillet 2015

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • BVT.BSSL-030

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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