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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 juli 2015 bijgewerkt door: 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.

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

415

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • België
      • Bruges, België
        • Swedish Orphan Biovitrum Investigational Site
      • Leuven, België
        • Swedish Orphan Biovitrum Investigational Site
      • Liege, België
        • Swedish Orphan Biovitrum Investigational Site
      • Rocourt, België
        • Swedish Orphan Biovitrum Investigational Site
      • Wilrijk, België
        • Swedish Orphan Biovitrum Investigational Site
  • Duitsland
      • Berlin, Duitsland
        • Swedish Orphan Biovitrum Investigational Site
      • Freiburg, Duitsland
        • Swedish Orphan Biovitrum Investigational Site
      • Heidelberg, Duitsland
        • Swedish Orphan Biovitrum Investigational Site
      • Wiesbaden, Duitsland
        • Swedish Orphan Biovitrum Investigational Site
  • Frankrijk
      • Amiens, Frankrijk
        • Swedish Orphan Biovitrum Investigational Site
      • Lille, Frankrijk
        • Swedish Orphan Biovitrum Investigational Site
      • Nancy, Frankrijk
        • Swedish Orphan Biovitrum Investigational Site
      • Paris, Frankrijk
        • Swedish Orphan Biovitrum Investigational Site
      • Rouen, Frankrijk
        • Swedish Orphan Biovitrum Investigational Site
      • Strasbourg, Frankrijk
        • Swedish Orphan Biovitrum Investigational Site
      • Toulouse, Frankrijk
        • Swedish Orphan Biovitrum Investigational Site
  • Hongarije
      • Budapest, Hongarije
        • Swedish Orphan Biovitrum Investigational Site
      • Gyula, Hongarije
        • Swedish Orphan Biovitrum Investigational Site
      • Miskolc, Hongarije
        • Swedish Orphan Biovitrum Investigational Site
      • Nyíregyháza, Hongarije
        • Swedish Orphan Biovitrum Investigational Site
      • Pécs, Hongarije
        • Swedish Orphan Biovitrum Investigational Site
      • Veszprem, Hongarije
        • Swedish Orphan Biovitrum Investigational Site
  • Italië
      • Ancona, Italië
        • Swedish Orphan Biovitrum Investigational Site
      • Bari, Italië
        • Swedish Orphan Biovitrum Investigational Site
      • Foggia, Italië
        • Swedish Orphan Biovitrum Investigational Site
      • Milano, Italië
        • Swedish Orphan Biovitrum Investigational Site
      • Padova, Italië
        • Swedish Orphan Biovitrum Investigational Site
      • Roma, Italië
        • Swedish Orphan Biovitrum Investigational Site
  • Polen
      • Bydgoszcz, Polen
        • Swedish Orphan Biovitrum Investigational Site
      • Gdansk, Polen
        • Swedish Orphan Biovitrum Investigational Site
      • Lodz, Polen
        • Swedish Orphan Biovitrum Investigational Site
      • Poznan, Polen
        • Swedish Orphan Biovitrum Investigational Site
      • Warszawa, Polen
        • Swedish Orphan Biovitrum Investigational Site
  • Russische Federatie
      • Ivanovo, Russische Federatie
        • Swedish Orphan Biovitrum Investigational Site
      • Nizhniy Novgorod, Russische Federatie
        • Swedish Orphan Biovitrum Investigational Site
  • Spanje
      • Almería, Spanje
        • Swedish Orphan Biovitrum Investigational Site
      • Cádiz, Spanje
        • Swedish Orphan Biovitrum Investigational Site
      • Córdoba, Spanje
        • Swedish Orphan Biovitrum Investigational Site
      • Madrid, Spanje
        • Swedish Orphan Biovitrum Investigational Site
      • Málaga, Spanje
        • Swedish Orphan Biovitrum Investigational Site
      • Oviedo, Spanje
        • Swedish Orphan Biovitrum Investigational Site
      • Salamanca, Spanje
        • Swedish Orphan Biovitrum Investigational Site
      • Santiago de Compostela, Spanje
        • Swedish Orphan Biovitrum Investigational Site
  • Tsjechische Republiek
      • Hradec Kralove, Tsjechische Republiek
        • Swedish Orphan Biovitrum Investigational Site
      • Olomouc, Tsjechische Republiek
        • Swedish Orphan Biovitrum Investigational Site
      • Prague, Tsjechische Republiek
        • Swedish Orphan Biovitrum Investigational Site
      • Zlin, Tsjechische Republiek
        • Swedish Orphan Biovitrum Investigational Site
  • Zweden
      • Stockholm, Zweden
        • Swedish Orphan Biovitrum Investigational Site
      • Umeå, Zweden
        • Swedish Orphan Biovitrum Investigational Site

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Niet ouder dan 2 maanden (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: Placebo
Geneesmiddel: Placebo
Placebo added to infant formula/pasteurized breast milk during a 4 week treatment period.
Experimenteel: rhBSSL
rhBSSL (recombinant human bile-salt-stimulated lipase)
Geneesmiddel: rhBSSL (recombinant human bile-salt-stimulated lipase)
rhBSSL added to infant formula/pasteurized breast milk during a 4 week treatment period.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Growth velocity in grams per kilogram per day during 4 weeks of treatment.
Tijdsspanne: Baseline and Day 29
Baseline and Day 29

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Swedish Orphan Biovitrum

Onderzoekers

  • Studie directeur: Kristina Timdahl, MD, Swedish Orphan Biovitrum

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 mei 2011

Primaire voltooiing (Werkelijk)

1 juli 2013

Studie voltooiing (Werkelijk)

1 augustus 2014

Studieregistratiedata

Eerst ingediend

8 juni 2011

Eerst ingediend dat voldeed aan de QC-criteria

9 augustus 2011

Eerst geplaatst (Schatting)

10 augustus 2011

Updates van studierecords

Laatste update geplaatst (Schatting)

30 juli 2015

Laatste update ingediend die voldeed aan QC-criteria

29 juli 2015

Laatst geverifieerd

1 juli 2015

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • BVT.BSSL-030

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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