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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 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

415

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • 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
  • Frankrike
      • Amiens, Frankrike
        • Swedish Orphan Biovitrum Investigational Site
      • Lille, Frankrike
        • Swedish Orphan Biovitrum Investigational Site
      • Nancy, Frankrike
        • Swedish Orphan Biovitrum Investigational Site
      • Paris, Frankrike
        • Swedish Orphan Biovitrum Investigational Site
      • Rouen, Frankrike
        • Swedish Orphan Biovitrum Investigational Site
      • Strasbourg, Frankrike
        • Swedish Orphan Biovitrum Investigational Site
      • Toulouse, Frankrike
        • 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
  • Ryska Federationen
      • Ivanovo, Ryska Federationen
        • Swedish Orphan Biovitrum Investigational Site
      • Nizhniy Novgorod, Ryska Federationen
        • 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
  • Sverige
      • Stockholm, Sverige
        • Swedish Orphan Biovitrum Investigational Site
      • Umeå, Sverige
        • Swedish Orphan Biovitrum Investigational Site
  • Tjeckien
      • Hradec Kralove, Tjeckien
        • Swedish Orphan Biovitrum Investigational Site
      • Olomouc, Tjeckien
        • Swedish Orphan Biovitrum Investigational Site
      • Prague, Tjeckien
        • Swedish Orphan Biovitrum Investigational Site
      • Zlin, Tjeckien
        • Swedish Orphan Biovitrum Investigational Site
  • Tyskland
      • Berlin, Tyskland
        • Swedish Orphan Biovitrum Investigational Site
      • Freiburg, Tyskland
        • Swedish Orphan Biovitrum Investigational Site
      • Heidelberg, Tyskland
        • Swedish Orphan Biovitrum Investigational Site
      • Wiesbaden, Tyskland
        • Swedish Orphan Biovitrum Investigational Site
  • Ungern
      • Budapest, Ungern
        • Swedish Orphan Biovitrum Investigational Site
      • Gyula, Ungern
        • Swedish Orphan Biovitrum Investigational Site
      • Miskolc, Ungern
        • Swedish Orphan Biovitrum Investigational Site
      • Nyíregyháza, Ungern
        • Swedish Orphan Biovitrum Investigational Site
      • Pécs, Ungern
        • Swedish Orphan Biovitrum Investigational Site
      • Veszprem, Ungern
        • Swedish Orphan Biovitrum Investigational Site

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Inte äldre än 2 månader (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: Placebo
Läkemedel: Placebo
Placebo added to infant formula/pasteurized breast milk during a 4 week treatment period.
Experimentell: rhBSSL
rhBSSL (recombinant human bile-salt-stimulated lipase)
Läkemedel: rhBSSL (recombinant human bile-salt-stimulated lipase)
rhBSSL added to infant formula/pasteurized breast milk during a 4 week treatment period.

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Swedish Orphan Biovitrum

Utredare

  • Studierektor: Kristina Timdahl, MD, Swedish Orphan Biovitrum

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 maj 2011

Primärt slutförande (Faktisk)

1 juli 2013

Avslutad studie (Faktisk)

1 augusti 2014

Studieregistreringsdatum

Först inskickad

8 juni 2011

Först inskickad som uppfyllde QC-kriterierna

9 augusti 2011

Första postat (Uppskatta)

10 augusti 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

30 juli 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 juli 2015

Senast verifierad

1 juli 2015

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • BVT.BSSL-030

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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