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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 luglio 2015 aggiornato da: 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.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

415

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Belgio
      • Bruges, Belgio
        • Swedish Orphan Biovitrum Investigational Site
      • Leuven, Belgio
        • Swedish Orphan Biovitrum Investigational Site
      • Liege, Belgio
        • Swedish Orphan Biovitrum Investigational Site
      • Rocourt, Belgio
        • Swedish Orphan Biovitrum Investigational Site
      • Wilrijk, Belgio
        • Swedish Orphan Biovitrum Investigational Site
  • Federazione Russa
      • Ivanovo, Federazione Russa
        • Swedish Orphan Biovitrum Investigational Site
      • Nizhniy Novgorod, Federazione Russa
        • 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
  • Germania
      • Berlin, Germania
        • Swedish Orphan Biovitrum Investigational Site
      • Freiburg, Germania
        • Swedish Orphan Biovitrum Investigational Site
      • Heidelberg, Germania
        • Swedish Orphan Biovitrum Investigational Site
      • Wiesbaden, Germania
        • 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
  • Repubblica Ceca
      • Hradec Kralove, Repubblica Ceca
        • Swedish Orphan Biovitrum Investigational Site
      • Olomouc, Repubblica Ceca
        • Swedish Orphan Biovitrum Investigational Site
      • Prague, Repubblica Ceca
        • Swedish Orphan Biovitrum Investigational Site
      • Zlin, Repubblica Ceca
        • Swedish Orphan Biovitrum Investigational Site
  • Spagna
      • Almería, Spagna
        • Swedish Orphan Biovitrum Investigational Site
      • Cádiz, Spagna
        • Swedish Orphan Biovitrum Investigational Site
      • Córdoba, Spagna
        • Swedish Orphan Biovitrum Investigational Site
      • Madrid, Spagna
        • Swedish Orphan Biovitrum Investigational Site
      • Málaga, Spagna
        • Swedish Orphan Biovitrum Investigational Site
      • Oviedo, Spagna
        • Swedish Orphan Biovitrum Investigational Site
      • Salamanca, Spagna
        • Swedish Orphan Biovitrum Investigational Site
      • Santiago de Compostela, Spagna
        • Swedish Orphan Biovitrum Investigational Site
  • Svezia
      • Stockholm, Svezia
        • Swedish Orphan Biovitrum Investigational Site
      • Umeå, Svezia
        • Swedish Orphan Biovitrum Investigational Site
  • Ungheria
      • Budapest, Ungheria
        • Swedish Orphan Biovitrum Investigational Site
      • Gyula, Ungheria
        • Swedish Orphan Biovitrum Investigational Site
      • Miskolc, Ungheria
        • Swedish Orphan Biovitrum Investigational Site
      • Nyíregyháza, Ungheria
        • Swedish Orphan Biovitrum Investigational Site
      • Pécs, Ungheria
        • Swedish Orphan Biovitrum Investigational Site
      • Veszprem, Ungheria
        • Swedish Orphan Biovitrum Investigational Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Non più vecchio di 2 mesi (Bambino)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo
Droga: Placebo
Placebo added to infant formula/pasteurized breast milk during a 4 week treatment period.
Sperimentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Growth velocity in grams per kilogram per day during 4 weeks of treatment.
Lasso di tempo: Baseline and Day 29
Baseline and Day 29

Misure di risultato secondarie

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Swedish Orphan Biovitrum

Investigatori

  • Direttore dello studio: Kristina Timdahl, MD, Swedish Orphan Biovitrum

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 maggio 2011

Completamento primario (Effettivo)

1 luglio 2013

Completamento dello studio (Effettivo)

1 agosto 2014

Date di iscrizione allo studio

Primo inviato

8 giugno 2011

Primo inviato che soddisfa i criteri di controllo qualità

9 agosto 2011

Primo Inserito (Stima)

10 agosto 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

30 luglio 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 luglio 2015

Ultimo verificato

1 luglio 2015

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • BVT.BSSL-030

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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