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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 aktualisiert von: 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.

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

415

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Belgien
      • Bruges, Belgien
        • Swedish Orphan Biovitrum Investigational Site
      • Leuven, Belgien
        • Swedish Orphan Biovitrum Investigational Site
      • Liege, Belgien
        • Swedish Orphan Biovitrum Investigational Site
      • Rocourt, Belgien
        • Swedish Orphan Biovitrum Investigational Site
      • Wilrijk, Belgien
        • Swedish Orphan Biovitrum Investigational Site
  • Deutschland
      • Berlin, Deutschland
        • Swedish Orphan Biovitrum Investigational Site
      • Freiburg, Deutschland
        • Swedish Orphan Biovitrum Investigational Site
      • Heidelberg, Deutschland
        • Swedish Orphan Biovitrum Investigational Site
      • Wiesbaden, Deutschland
        • Swedish Orphan Biovitrum Investigational Site
  • Frankreich
      • Amiens, Frankreich
        • Swedish Orphan Biovitrum Investigational Site
      • Lille, Frankreich
        • Swedish Orphan Biovitrum Investigational Site
      • Nancy, Frankreich
        • Swedish Orphan Biovitrum Investigational Site
      • Paris, Frankreich
        • Swedish Orphan Biovitrum Investigational Site
      • Rouen, Frankreich
        • Swedish Orphan Biovitrum Investigational Site
      • Strasbourg, Frankreich
        • Swedish Orphan Biovitrum Investigational Site
      • Toulouse, Frankreich
        • Swedish Orphan Biovitrum Investigational Site
  • Italien
      • Ancona, Italien
        • Swedish Orphan Biovitrum Investigational Site
      • Bari, Italien
        • Swedish Orphan Biovitrum Investigational Site
      • Foggia, Italien
        • Swedish Orphan Biovitrum Investigational Site
      • Milano, Italien
        • Swedish Orphan Biovitrum Investigational Site
      • Padova, Italien
        • Swedish Orphan Biovitrum Investigational Site
      • Roma, Italien
        • 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 Föderation
      • Ivanovo, Russische Föderation
        • Swedish Orphan Biovitrum Investigational Site
      • Nizhniy Novgorod, Russische Föderation
        • Swedish Orphan Biovitrum Investigational Site
  • Schweden
      • Stockholm, Schweden
        • Swedish Orphan Biovitrum Investigational Site
      • Umeå, Schweden
        • Swedish Orphan Biovitrum Investigational Site
  • Spanien
      • Almería, Spanien
        • Swedish Orphan Biovitrum Investigational Site
      • Cádiz, Spanien
        • Swedish Orphan Biovitrum Investigational Site
      • Córdoba, Spanien
        • Swedish Orphan Biovitrum Investigational Site
      • Madrid, Spanien
        • Swedish Orphan Biovitrum Investigational Site
      • Málaga, Spanien
        • Swedish Orphan Biovitrum Investigational Site
      • Oviedo, Spanien
        • Swedish Orphan Biovitrum Investigational Site
      • Salamanca, Spanien
        • Swedish Orphan Biovitrum Investigational Site
      • Santiago de Compostela, Spanien
        • Swedish Orphan Biovitrum Investigational Site
  • Tschechische Republik
      • Hradec Kralove, Tschechische Republik
        • Swedish Orphan Biovitrum Investigational Site
      • Olomouc, Tschechische Republik
        • Swedish Orphan Biovitrum Investigational Site
      • Prague, Tschechische Republik
        • Swedish Orphan Biovitrum Investigational Site
      • Zlin, Tschechische Republik
        • Swedish Orphan Biovitrum Investigational Site
  • Ungarn
      • Budapest, Ungarn
        • Swedish Orphan Biovitrum Investigational Site
      • Gyula, Ungarn
        • Swedish Orphan Biovitrum Investigational Site
      • Miskolc, Ungarn
        • Swedish Orphan Biovitrum Investigational Site
      • Nyíregyháza, Ungarn
        • Swedish Orphan Biovitrum Investigational Site
      • Pécs, Ungarn
        • Swedish Orphan Biovitrum Investigational Site
      • Veszprem, Ungarn
        • Swedish Orphan Biovitrum Investigational Site

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

Nicht älter als 2 Monate (Kind)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: Placebo
Arzneimittel: Placebo
Placebo added to infant formula/pasteurized breast milk during a 4 week treatment period.
Experimental: rhBSSL
rhBSSL (recombinant human bile-salt-stimulated lipase)
Arzneimittel: rhBSSL (recombinant human bile-salt-stimulated lipase)
rhBSSL added to infant formula/pasteurized breast milk during a 4 week treatment period.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Growth velocity in grams per kilogram per day during 4 weeks of treatment.
Zeitfenster: Baseline and Day 29
Baseline and Day 29

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Swedish Orphan Biovitrum

Ermittler

  • Studienleiter: Kristina Timdahl, MD, Swedish Orphan Biovitrum

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Mai 2011

Primärer Abschluss (Tatsächlich)

1. Juli 2013

Studienabschluss (Tatsächlich)

1. August 2014

Studienanmeldedaten

Zuerst eingereicht

8. Juni 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. August 2011

Zuerst gepostet (Schätzen)

10. August 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

30. Juli 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. Juli 2015

Zuletzt verifiziert

1. Juli 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • BVT.BSSL-030

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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