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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 oppdatert 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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Faktiske)

415

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Belgia
      • Bruges, Belgia
        • Swedish Orphan Biovitrum Investigational Site
      • Leuven, Belgia
        • Swedish Orphan Biovitrum Investigational Site
      • Liege, Belgia
        • Swedish Orphan Biovitrum Investigational Site
      • Rocourt, Belgia
        • Swedish Orphan Biovitrum Investigational Site
      • Wilrijk, Belgia
        • Swedish Orphan Biovitrum Investigational Site
  • Den russiske føderasjonen
      • Ivanovo, Den russiske føderasjonen
        • Swedish Orphan Biovitrum Investigational Site
      • Nizhniy Novgorod, Den russiske føderasjonen
        • 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
  • 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
  • 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
  • Spania
      • Almería, Spania
        • Swedish Orphan Biovitrum Investigational Site
      • Cádiz, Spania
        • Swedish Orphan Biovitrum Investigational Site
      • Córdoba, Spania
        • Swedish Orphan Biovitrum Investigational Site
      • Madrid, Spania
        • Swedish Orphan Biovitrum Investigational Site
      • Málaga, Spania
        • Swedish Orphan Biovitrum Investigational Site
      • Oviedo, Spania
        • Swedish Orphan Biovitrum Investigational Site
      • Salamanca, Spania
        • Swedish Orphan Biovitrum Investigational Site
      • Santiago de Compostela, Spania
        • Swedish Orphan Biovitrum Investigational Site
  • Sverige
      • Stockholm, Sverige
        • Swedish Orphan Biovitrum Investigational Site
      • Umeå, Sverige
        • Swedish Orphan Biovitrum Investigational Site
  • Tsjekkisk Republikk
      • Hradec Kralove, Tsjekkisk Republikk
        • Swedish Orphan Biovitrum Investigational Site
      • Olomouc, Tsjekkisk Republikk
        • Swedish Orphan Biovitrum Investigational Site
      • Prague, Tsjekkisk Republikk
        • Swedish Orphan Biovitrum Investigational Site
      • Zlin, Tsjekkisk Republikk
        • 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
  • 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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Ikke eldre enn 2 måneder (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo
Legemiddel: Placebo
Placebo added to infant formula/pasteurized breast milk during a 4 week treatment period.
Eksperimentell: rhBSSL
rhBSSL (recombinant human bile-salt-stimulated lipase)
Legemiddel: rhBSSL (recombinant human bile-salt-stimulated lipase)
rhBSSL added to infant formula/pasteurized breast milk during a 4 week treatment period.

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Swedish Orphan Biovitrum

Etterforskere

  • Studieleder: Kristina Timdahl, MD, Swedish Orphan Biovitrum

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mai 2011

Primær fullføring (Faktiske)

1. juli 2013

Studiet fullført (Faktiske)

1. august 2014

Datoer for studieregistrering

Først innsendt

8. juni 2011

Først innsendt som oppfylte QC-kriteriene

9. august 2011

Først lagt ut (Anslag)

10. august 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

30. juli 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. juli 2015

Sist bekreftet

1. juli 2015

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • BVT.BSSL-030

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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