Prevention of Growth RestrictionPhase 3LAIFNCT01413581
Comparison of rhBSSL With Placebo When Added to Infant Formula or Pasteurized Breast Milk During 4 Weeks of Treatment in Preterm Infants
A Phase 3 study testing rhBSSL (recombinant human bile-salt-stimulated lipase) in people with Prevention of Growth Restriction, run by Swedish Orphan Biovitrum at 49 sites in 10 countries.
Trial summary
The purpose of this study is to demonstrate that rhBSSL improves growth in preterm infants as compared with placebo. Read more about this study
- Who is it for?
- Ages Up to 10 weeks
- Conditions the study is for
- Prevention of Growth Restriction
- What is being tested?
- rhBSSL (recombinant human bile-salt-stimulated lipase)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 415 participants
- Where
- 49 sitesin 10 countries
- Study dates
- May 2011to Aug 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 10 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
49 sites in 10 countries.
49 sites in 10 countries
Spain8 sites
Swedish Orphan Biovitrum Investigational Site
Almería
Swedish Orphan Biovitrum Investigational Site
Cadiz
Swedish Orphan Biovitrum Investigational Site
Córdoba
Swedish Orphan Biovitrum Investigational Site
Madrid
Swedish Orphan Biovitrum Investigational Site
Málaga
Swedish Orphan Biovitrum Investigational Site
Oviedo
Swedish Orphan Biovitrum Investigational Site
Salamanca
Swedish Orphan Biovitrum Investigational Site
Santiago de Compostela
France7 sites
Swedish Orphan Biovitrum Investigational Site
Amiens
Swedish Orphan Biovitrum Investigational Site
Lille
Swedish Orphan Biovitrum Investigational Site
Nancy
Swedish Orphan Biovitrum Investigational Site
Paris
Swedish Orphan Biovitrum Investigational Site
Rouen
Swedish Orphan Biovitrum Investigational Site
Strasbourg
Swedish Orphan Biovitrum Investigational Site
Toulouse
Hungary6 sites
Swedish Orphan Biovitrum Investigational Site
Budapest
Swedish Orphan Biovitrum Investigational Site
Gyula
Swedish Orphan Biovitrum Investigational Site
Miskolc
Swedish Orphan Biovitrum Investigational Site
Nyíregyháza
Swedish Orphan Biovitrum Investigational Site
Pécs
Swedish Orphan Biovitrum Investigational Site
Veszprém
Italy6 sites
Swedish Orphan Biovitrum Investigational Site
Ancona
Swedish Orphan Biovitrum Investigational Site
Bari
Swedish Orphan Biovitrum Investigational Site
Foggia
Swedish Orphan Biovitrum Investigational Site
Milan
Swedish Orphan Biovitrum Investigational Site
Padova
Swedish Orphan Biovitrum Investigational Site
Roma
Belgium5 sites
Swedish Orphan Biovitrum Investigational Site
Bruges
Swedish Orphan Biovitrum Investigational Site
Leuven
Swedish Orphan Biovitrum Investigational Site
Liège
Swedish Orphan Biovitrum Investigational Site
Rocourt
Swedish Orphan Biovitrum Investigational Site
Wilrijk
Poland5 sites
Swedish Orphan Biovitrum Investigational Site
Bydgoszcz
Swedish Orphan Biovitrum Investigational Site
Gdansk
Swedish Orphan Biovitrum Investigational Site
Lodz
Swedish Orphan Biovitrum Investigational Site
Poznan
Swedish Orphan Biovitrum Investigational Site
Warsaw
Czechia4 sites
Swedish Orphan Biovitrum Investigational Site
Hradec Králové
Swedish Orphan Biovitrum Investigational Site
Olomouc
Swedish Orphan Biovitrum Investigational Site
Prague
Swedish Orphan Biovitrum Investigational Site
Zlín
Germany4 sites
Swedish Orphan Biovitrum Investigational Site
Berlin
Swedish Orphan Biovitrum Investigational Site
Freiburg im Breisgau
Swedish Orphan Biovitrum Investigational Site
Heidelberg
Swedish Orphan Biovitrum Investigational Site
Wiesbaden
Russia2 sites
Swedish Orphan Biovitrum Investigational Site
Ivanovo
Swedish Orphan Biovitrum Investigational Site
Nizhny Novgorod
Sweden2 sites
Swedish Orphan Biovitrum Investigational Site
Stockholm
Swedish Orphan Biovitrum Investigational Site
Umeå
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Prevention of Growth Restriction
- Being tested
- rhBSSL (recombinant human bile-salt-stimulated lipase), Placebo
- Keywords
- rhBSSL, preterm infants, Swedish Orphan Biovitrum, growth velocity, Prevention of growth restriction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhBSSL (recombinant human bile-salt-stimulated lipase)Drug
rhBSSL added to infant formula/pasteurized breast milk during a 4 week treatment period.
PlaceboDrug
Placebo added to infant formula/pasteurized breast milk during a 4 week treatment period.
| Study group | Role | What they receive |
|---|---|---|
| rhBSSL | Experimental | rhBSSL (recombinant human bile-salt-stimulated lipase) Receives: Drug: rhBSSL (recombinant human bile-salt-stimulated lipase) |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth velocity in grams per kilogram per day during 4 weeks of treatment.
Measured: Baseline and Day 29
Secondary outcomes (46)
Change from baseline in body weight (g) at 3 months
Measured: Baseline and Month 3
Body weight (g) at 12 months' corrected age
Measured: 12 months´ corrected age
Body weight (g) at 24 months' corrected age
Measured: 24 months´ corrected age
Change from baseline in total body length (mm) at 4 weeks
Measured: Baseline and Day 29
Change from baseline in total body length (mm) at 3 months
Measured: Baseline and Month 3
Total body length (mm) at 12 months' corrected age
Measured: 12 months' corrected age
Total body height (cm) at 24 months' corrected age
Measured: 24 months' corrected age
Growth restriction
Defined as growth velocity <15 gram per kilogram bodyweight per day during 4 weeks of treatment
Measured: Day 29
Time to 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
Measured: Baseline and date of readiness for discharge
Time to discharge
Measured: Baseline and date of discharge
Change from baseline in head circumference (mm) at 4 weeks.
Measured: Baseline and Day 29
Change from baseline in head circumference (mm) at 3 months.
Measured: Baseline and Month 3
Head circumference (mm) at 12 months' corrected age.
Measured: 12 months´ corrected age
Head circumference (mm) at 24 months' corrected age.
Measured: 24 months´ corrected age
Time from baseline to 150 mL/kg/day of enteral feeding
Measured: 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
Measured: 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
Measured: 12 months' corrected age
Bayley Scale of Infant and Toddler Development, third edition: Cognitive domain composite score at 24 months' corrected age
Measured: 24 months' corrected age
Bayley Scale of Infant and Toddler Development, third edition: Language domain composite score at 12 months' corrected age
Measured: 12 months' corrected age
Bayley Scale of Infant and Toddler Development, third edition: Language domain composite score at 24 months' corrected age
Measured: 24 months' corrected age
Bayley Scale of Infant and Toddler Development, third edition: Motor domain composite score at 12 months' corrected age
Measured: 12 months' corrected age
Bayley Scale of Infant and Toddler Development, third edition: Motor domain composite score at 24 months' corrected age
Measured: 24 months' corrected age
Bayley Scale of Infant and Toddler Development, third edition: Social-emotional domain composite score at 24 months' corrected age
Measured: 24 months' corrected age
Bayley Scale of Infant and Toddler Development, third edition: Adaptive behavior domain composite score at 24 months' corrected age
Measured: 24 months' corrected age
Neurodevelopment Disability Composite
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
Measured: 24 months' corrected age
Child Behavior Checklist total problem score at 24 months' corrected age
Measured: 24 months' corrected age visit
Number of patients with at least one treatment emergent Adverse Event
Total and by system organ class and preferred term (coded by MedDRA)
Measured: Baseline and Day 29
Number of patients with at least one treatment emergent Adverse Event
Total and by system organ class and preferred term (coded by MedDRA)
Measured: Day 29 and Month 3
Number of patients with at least one treatment emergent Serious Adverse Event
Total and by system organ class and preferred term (coded by MedDRA)
Measured: Baseline and Day 29
Number of patients with at least one treatment emergent Serious Adverse Event
Total and by system organ class and preferred term (coded by MedDRA)
Measured: Day 29 and Month 3
Number of patients with at least one Serious Adverse Drug Reaction
Total and by system organ class and preferred term (coded by MedDRA)
Measured: 12 months' corrected age and 24 months' corrected age
Level of Vitamin A (nmol/L) at 4 weeks
Measured: Day 29
Level of Vitamin D (nmol/L) at 4 weeks
Measured: Day 29
Number of outpatient visits from the time of initial hospital discharge to home up to 24 months' corrected age
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 24 months' corrected age
Docosahexaenoic acid (% of total fatty acids) in the serum triglyceride fraction at 4 weeks
Measured: Day 29
Docosahexaenoic acid (% of total fatty acids) in the serum phosphatidylcholine fraction at 4 weeks
Measured: Day 29
Arachidonic acid (% of total fatty acids) in the serum triglyceride fraction at 4 weeks
Measured: Day 29
Arachidonic acid (% of total fatty acids) in the serum phosphatidylcholine fraction at 4 weeks
Measured: Day 29
Number of patients with antibodies to rhBSSL at 4 weeks
Measured: Day 29
Number of patients with antibodies to rhBSSL at Month 3
Measured: Month 3
Number of patients with antibodies to rhBSSL at 12 months' corrected age
Measured: 12 months' corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2011 (estimated)
- Study startMay 2011
- Primary completionJul 2013
- Study completionAug 2014
Why it stopped: Primary endpoint showed no stat significant difference. FU \> M12 terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prevention of Growth RestrictionStudies of the same condition, open and under way.
- More trials run by Swedish Orphan BiovitrumThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Orphan Biovitrum
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristina Timdahl, MD, Study director, Swedish Orphan Biovitrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01413581
- Sponsor's protocol ID
- BVT.BSSL-030
- Acronym
- LAIF
- Status last verified
- Jul 2015
- First submitted
- 8 Jun 2011
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Casper C, Hascoet JM, Ertl T, Gadzinowski JS, Carnielli V, Rigo J, Lapillonne A, Couce ML, Vagero M, Palmgren I, Timdahl K, Hernell O. Recombinant Bile Salt-Stimulated Lipase in Preterm Infant Feeding: A Randomized Phase 3 Study. PLoS One. 2016 May 31;11(5):e0156071. doi: 10.1371/journal.pone.0156071. eCollection 2016.
PubMed 27244221Casper C, Carnielli VP, Hascoet JM, Lapillonne A, Maggio L, Timdahl K, Olsson B, Vagero M, Hernell O. rhBSSL improves growth and LCPUFA absorption in preterm infants fed formula or pasteurized breast milk. J Pediatr Gastroenterol Nutr. 2014 Jul;59(1):61-9. doi: 10.1097/MPG.0000000000000365.
PubMed 25222806
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01413581
- Acronym / sponsor ID
- LAIF / BVT.BSSL-030
- Conditions
- Prevention of Growth Restriction
- Keywords
- rhBSSL, preterm infants, Swedish Orphan Biovitrum, growth velocity, Prevention of growth restriction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Primary endpoint showed no stat significant difference. FU \> M12 terminated.
- Enrolment
- 415 participants (actual)
- Lead sponsor
- Swedish Orphan BiovitrumIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 10 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate that rhBSSL improves growth in preterm infants as compared with placebo.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rhBSSL | Experimental | Drug: rhBSSL (recombinant human bile-salt-stimulated lipase)rhBSSL (recombinant human bile-salt-stimulated lipase) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- Up to 10 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rhBSSL (recombinant human bile-salt-stimulated lipase)rhBSSL added to infant formula/pasteurized breast milk during a 4 week treatment period. | Drug | rhBSSL |
| PlaceboPlacebo added to infant formula/pasteurized breast milk during a 4 week treatment period. | Drug | Placebo |
Primary outcome
Growth velocity in grams per kilogram per day during 4 weeks of treatment.
Time frame: Baseline and Day 29
46 secondary outcomes
Change from baseline in body weight (g) at 3 months
Time frame: Baseline and Month 3
Body weight (g) at 12 months' corrected age
Time frame: 12 months´ corrected age
Body weight (g) at 24 months' corrected age
Time frame: 24 months´ corrected age
Change from baseline in total body length (mm) at 4 weeks
Time frame: Baseline and Day 29
Change from baseline in total body length (mm) at 3 months
Time frame: Baseline and Month 3
Total body length (mm) at 12 months' corrected age
Time frame: 12 months' corrected age
Total body height (cm) at 24 months' corrected age
Time frame: 24 months' corrected age
Growth restriction
Time frame: Day 29
Time to readiness for discharge
Time frame: Baseline and date of readiness for discharge
Time to discharge
Time frame: Baseline and date of discharge
Change from baseline in head circumference (mm) at 4 weeks.
Time frame: Baseline and Day 29
Change from baseline in head circumference (mm) at 3 months.
Time frame: Baseline and Month 3
Head circumference (mm) at 12 months' corrected age.
Time frame: 12 months´ corrected age
Head circumference (mm) at 24 months' corrected age.
Time frame: 24 months´ corrected age
Time from baseline to 150 mL/kg/day of enteral feeding
Time frame: 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
Time frame: 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
Time frame: 12 months' corrected age
Bayley Scale of Infant and Toddler Development, third edition: Cognitive domain composite score at 24 months' corrected age
Time frame: 24 months' corrected age
Bayley Scale of Infant and Toddler Development, third edition: Language domain composite score at 12 months' corrected age
Time frame: 12 months' corrected age
Bayley Scale of Infant and Toddler Development, third edition: Language domain composite score at 24 months' corrected age
Time frame: 24 months' corrected age
Bayley Scale of Infant and Toddler Development, third edition: Motor domain composite score at 12 months' corrected age
Time frame: 12 months' corrected age
Bayley Scale of Infant and Toddler Development, third edition: Motor domain composite score at 24 months' corrected age
Time frame: 24 months' corrected age
Bayley Scale of Infant and Toddler Development, third edition: Social-emotional domain composite score at 24 months' corrected age
Time frame: 24 months' corrected age
Bayley Scale of Infant and Toddler Development, third edition: Adaptive behavior domain composite score at 24 months' corrected age
Time frame: 24 months' corrected age
Neurodevelopment Disability Composite
Time frame: 24 months' corrected age
Child Behavior Checklist total problem score at 24 months' corrected age
Time frame: 24 months' corrected age visit
Number of patients with at least one treatment emergent Adverse Event
Time frame: Baseline and Day 29
Number of patients with at least one treatment emergent Adverse Event
Time frame: Day 29 and Month 3
Number of patients with at least one treatment emergent Serious Adverse Event
Time frame: Baseline and Day 29
Number of patients with at least one treatment emergent Serious Adverse Event
Time frame: Day 29 and Month 3
Number of patients with at least one Serious Adverse Drug Reaction
Time frame: 12 months' corrected age and 24 months' corrected age
Level of Vitamin A (nmol/L) at 4 weeks
Time frame: Day 29
Level of Vitamin D (nmol/L) at 4 weeks
Time frame: Day 29
Number of outpatient visits from the time of initial hospital discharge to home up to 24 months' corrected age
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 24 months' corrected age
Docosahexaenoic acid (% of total fatty acids) in the serum triglyceride fraction at 4 weeks
Time frame: Day 29
Results and safety
The study was stopped early (reason given: Primary endpoint showed no stat significant difference. FU \> M12 terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
- Derived from this study: PubMed 27244221Casper C, Hascoet JM, Ertl T, Gadzinowski JS, Carnielli V, Rigo J, Lapillonne A, Couce ML, Vagero M, Palmgren I, Timdahl K, Hernell O. Recombinant Bile Salt-Stimulated Lipase in Preterm Infant Feeding: A Randomized Phase 3 Study. PLoS One. 2016 May 31;11(5):e0156071. doi: 10.1371/journal.pone.0156071. eCollection 2016.
- Derived from this study: PubMed 25222806Casper C, Carnielli VP, Hascoet JM, Lapillonne A, Maggio L, Timdahl K, Olsson B, Vagero M, Hernell O. rhBSSL improves growth and LCPUFA absorption in preterm infants fed formula or pasteurized breast milk. J Pediatr Gastroenterol Nutr. 2014 Jul;59(1):61-9. doi: 10.1097/MPG.0000000000000365.
- Results are available on the European Union Clinical Trials RegisterLink provided by the sponsor.
Related trials for Prevention of Growth Restriction
RecruitingObservational study
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GDM, Preterm Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristina Timdahl, MD study director
Swedish Orphan Biovitrum
49 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rhBSSL (recombinant human bile-salt-stimulated lipase) in people with Prevention of Growth Restriction, run by Swedish Orphan Biovitrum at 49 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in Spain, France, Hungary, Italy, Belgium and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Primary endpoint showed no stat significant difference. FU \> M12 terminated.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth velocity in grams per kilogram per day during 4 weeks of treatment. (time frame: Baseline and Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01413581, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2015.