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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)

Primary Purpose

Prevention of Growth Restriction

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
rhBSSL (recombinant human bile-salt-stimulated lipase)
Placebo
Sponsored by
Swedish Orphan Biovitrum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prevention of Growth Restriction focused on measuring rhBSSL, preterm infants, Swedish Orphan Biovitrum, growth velocity, Prevention of growth restriction

Eligibility Criteria

undefined - 10 Weeks (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site
  • Swedish Orphan Biovitrum Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

rhBSSL

Placebo

Arm Description

rhBSSL (recombinant human bile-salt-stimulated lipase)

Placebo

Outcomes

Primary Outcome Measures

Growth velocity in grams per kilogram per day during 4 weeks of treatment.

Secondary Outcome Measures

Change from baseline in body weight (g) at 3 months
Body weight (g) at 12 months' corrected age
Body weight (g) at 24 months' corrected age
Change from baseline in total body length (mm) at 4 weeks
Change from baseline in total body length (mm) at 3 months
Total body length (mm) at 12 months' corrected age
Total body height (cm) at 24 months' corrected age
Growth restriction
Defined as growth velocity <15 gram per kilogram bodyweight per day during 4 weeks of treatment
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
Time to discharge
Change from baseline in head circumference (mm) at 4 weeks.
Change from baseline in head circumference (mm) at 3 months.
Head circumference (mm) at 12 months' corrected age.
Head circumference (mm) at 24 months' corrected age.
Time from baseline to 150 mL/kg/day of enteral feeding
Re-admission to hospital within 1 month of discharge
Bayley Scale of Infant and Toddler Development, third edition: Cognitive domain composite score 12 months' corrected age
Bayley Scale of Infant and Toddler Development, third edition: Cognitive domain composite score at 24 months' corrected age
Bayley Scale of Infant and Toddler Development, third edition: Language domain composite score at 12 months' corrected age
Bayley Scale of Infant and Toddler Development, third edition: Language domain composite score at 24 months' corrected age
Bayley Scale of Infant and Toddler Development, third edition: Motor domain composite score at 12 months' corrected age
Bayley Scale of Infant and Toddler Development, third edition: Motor domain composite score at 24 months' corrected age
Bayley Scale of Infant and Toddler Development, third edition: Social-emotional domain composite score at 24 months' corrected age
Bayley Scale of Infant and Toddler Development, third edition: Adaptive behavior domain composite score at 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
Child Behavior Checklist total problem score at 24 months' corrected age
Number of patients with at least one treatment emergent Adverse Event
Total and by system organ class and preferred term (coded by MedDRA)
Number of patients with at least one treatment emergent Adverse Event
Total and by system organ class and preferred term (coded by MedDRA)
Number of patients with at least one treatment emergent Serious Adverse Event
Total and by system organ class and preferred term (coded by MedDRA)
Number of patients with at least one treatment emergent Serious Adverse Event
Total and by system organ class and preferred term (coded by MedDRA)
Number of patients with at least one Serious Adverse Drug Reaction
Total and by system organ class and preferred term (coded by MedDRA)
Level of Vitamin A (nmol/L) at 4 weeks
Level of Vitamin D (nmol/L) at 4 weeks
Number of outpatient visits from the time of initial hospital discharge to home up to 24 months' corrected age
Number of inpatient visits from the time of initial hospital discharge to home up to 24 months' corrected age
Number of days of hospitalization from the time of initial hospital discharge to home up to 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
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
Presence of chronic medical conditions/diagnoses at 24 months' corrected age
Docosahexaenoic acid (% of total fatty acids) in the serum triglyceride fraction at 4 weeks
Docosahexaenoic acid (% of total fatty acids) in the serum phosphatidylcholine fraction at 4 weeks
Arachidonic acid (% of total fatty acids) in the serum triglyceride fraction at 4 weeks
Arachidonic acid (% of total fatty acids) in the serum phosphatidylcholine fraction at 4 weeks
Number of patients with antibodies to rhBSSL at 4 weeks
Number of patients with antibodies to rhBSSL at Month 3
Number of patients with antibodies to rhBSSL at 12 months' corrected age

Full Information

First Posted
June 8, 2011
Last Updated
July 29, 2015
Sponsor
Swedish Orphan Biovitrum
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1. Study Identification

Unique Protocol Identification Number
NCT01413581
Brief Title
Comparison of rhBSSL With Placebo When Added to Infant Formula or Pasteurized Breast Milk During 4 Weeks of Treatment in Preterm Infants
Acronym
LAIF
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Terminated
Why Stopped
Primary endpoint showed no stat significant difference. FU > M12 terminated.
Study Start Date
May 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swedish Orphan Biovitrum

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention of Growth Restriction
Keywords
rhBSSL, preterm infants, Swedish Orphan Biovitrum, growth velocity, Prevention of growth restriction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
415 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rhBSSL
Arm Type
Experimental
Arm Description
rhBSSL (recombinant human bile-salt-stimulated lipase)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
rhBSSL (recombinant human bile-salt-stimulated lipase)
Intervention Description
rhBSSL added to infant formula/pasteurized breast milk during a 4 week treatment period.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo added to infant formula/pasteurized breast milk during a 4 week treatment period.
Primary Outcome Measure Information:
Title
Growth velocity in grams per kilogram per day during 4 weeks of treatment.
Time Frame
Baseline and Day 29
Secondary Outcome Measure Information:
Title
Change from baseline in body weight (g) at 3 months
Time Frame
Baseline and Month 3
Title
Body weight (g) at 12 months' corrected age
Time Frame
12 months´ corrected age
Title
Body weight (g) at 24 months' corrected age
Time Frame
24 months´ corrected age
Title
Change from baseline in total body length (mm) at 4 weeks
Time Frame
Baseline and Day 29
Title
Change from baseline in total body length (mm) at 3 months
Time Frame
Baseline and Month 3
Title
Total body length (mm) at 12 months' corrected age
Time Frame
12 months' corrected age
Title
Total body height (cm) at 24 months' corrected age
Time Frame
24 months' corrected age
Title
Growth restriction
Description
Defined as growth velocity <15 gram per kilogram bodyweight per day during 4 weeks of treatment
Time Frame
Day 29
Title
Time to readiness for discharge
Description
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
Time Frame
Baseline and date of readiness for discharge
Title
Time to discharge
Time Frame
Baseline and date of discharge
Title
Change from baseline in head circumference (mm) at 4 weeks.
Time Frame
Baseline and Day 29
Title
Change from baseline in head circumference (mm) at 3 months.
Time Frame
Baseline and Month 3
Title
Head circumference (mm) at 12 months' corrected age.
Time Frame
12 months´ corrected age
Title
Head circumference (mm) at 24 months' corrected age.
Time Frame
24 months´ corrected age
Title
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)
Title
Re-admission to hospital within 1 month of discharge
Time Frame
Date of discharge and date of re-admission
Title
Bayley Scale of Infant and Toddler Development, third edition: Cognitive domain composite score 12 months' corrected age
Time Frame
12 months' corrected age
Title
Bayley Scale of Infant and Toddler Development, third edition: Cognitive domain composite score at 24 months' corrected age
Time Frame
24 months' corrected age
Title
Bayley Scale of Infant and Toddler Development, third edition: Language domain composite score at 12 months' corrected age
Time Frame
12 months' corrected age
Title
Bayley Scale of Infant and Toddler Development, third edition: Language domain composite score at 24 months' corrected age
Time Frame
24 months' corrected age
Title
Bayley Scale of Infant and Toddler Development, third edition: Motor domain composite score at 12 months' corrected age
Time Frame
12 months' corrected age
Title
Bayley Scale of Infant and Toddler Development, third edition: Motor domain composite score at 24 months' corrected age
Time Frame
24 months' corrected age
Title
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
Title
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
Title
Neurodevelopment Disability Composite
Description
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
Time Frame
24 months' corrected age
Title
Child Behavior Checklist total problem score at 24 months' corrected age
Time Frame
24 months' corrected age visit
Title
Number of patients with at least one treatment emergent Adverse Event
Description
Total and by system organ class and preferred term (coded by MedDRA)
Time Frame
Baseline and Day 29
Title
Number of patients with at least one treatment emergent Adverse Event
Description
Total and by system organ class and preferred term (coded by MedDRA)
Time Frame
Day 29 and Month 3
Title
Number of patients with at least one treatment emergent Serious Adverse Event
Description
Total and by system organ class and preferred term (coded by MedDRA)
Time Frame
Baseline and Day 29
Title
Number of patients with at least one treatment emergent Serious Adverse Event
Description
Total and by system organ class and preferred term (coded by MedDRA)
Time Frame
Day 29 and Month 3
Title
Number of patients with at least one Serious Adverse Drug Reaction
Description
Total and by system organ class and preferred term (coded by MedDRA)
Time Frame
12 months' corrected age and 24 months' corrected age
Title
Level of Vitamin A (nmol/L) at 4 weeks
Time Frame
Day 29
Title
Level of Vitamin D (nmol/L) at 4 weeks
Time Frame
Day 29
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Presence of chronic medical conditions/diagnoses at 24 months' corrected age
Time Frame
24 months' corrected age
Title
Docosahexaenoic acid (% of total fatty acids) in the serum triglyceride fraction at 4 weeks
Time Frame
Day 29
Title
Docosahexaenoic acid (% of total fatty acids) in the serum phosphatidylcholine fraction at 4 weeks
Time Frame
Day 29
Title
Arachidonic acid (% of total fatty acids) in the serum triglyceride fraction at 4 weeks
Time Frame
Day 29
Title
Arachidonic acid (% of total fatty acids) in the serum phosphatidylcholine fraction at 4 weeks
Time Frame
Day 29
Title
Number of patients with antibodies to rhBSSL at 4 weeks
Time Frame
Day 29
Title
Number of patients with antibodies to rhBSSL at Month 3
Time Frame
Month 3
Title
Number of patients with antibodies to rhBSSL at 12 months' corrected age
Time Frame
12 months' corrected age

10. Eligibility

Sex
All
Maximum Age & Unit of Time
10 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristina Timdahl, MD
Organizational Affiliation
Swedish Orphan Biovitrum
Official's Role
Study Director
Facility Information:
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Bruges
Country
Belgium
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Leuven
Country
Belgium
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Liege
Country
Belgium
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Rocourt
Country
Belgium
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Wilrijk
Country
Belgium
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Hradec Kralove
Country
Czech Republic
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Olomouc
Country
Czech Republic
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Prague
Country
Czech Republic
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Zlin
Country
Czech Republic
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Amiens
Country
France
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Lille
Country
France
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Nancy
Country
France
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Paris
Country
France
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Rouen
Country
France
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Strasbourg
Country
France
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Toulouse
Country
France
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Berlin
Country
Germany
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Freiburg
Country
Germany
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Heidelberg
Country
Germany
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Wiesbaden
Country
Germany
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Budapest
Country
Hungary
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Gyula
Country
Hungary
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Miskolc
Country
Hungary
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Nyíregyháza
Country
Hungary
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Pécs
Country
Hungary
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Veszprem
Country
Hungary
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Ancona
Country
Italy
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Bari
Country
Italy
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Foggia
Country
Italy
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Milano
Country
Italy
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Padova
Country
Italy
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Roma
Country
Italy
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Bydgoszcz
Country
Poland
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Gdansk
Country
Poland
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Lodz
Country
Poland
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Poznan
Country
Poland
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Warszawa
Country
Poland
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Ivanovo
Country
Russian Federation
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Nizhniy Novgorod
Country
Russian Federation
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Almería
Country
Spain
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Cádiz
Country
Spain
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Córdoba
Country
Spain
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Madrid
Country
Spain
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Málaga
Country
Spain
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Oviedo
Country
Spain
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Salamanca
Country
Spain
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Santiago de Compostela
Country
Spain
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Stockholm
Country
Sweden
Facility Name
Swedish Orphan Biovitrum Investigational Site
City
Umeå
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
27244221
Citation
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.
Results Reference
derived
PubMed Identifier
25222806
Citation
Casper 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 Reference
derived
Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/trial/2010-023909-35/results
Description
Results are available on the European Union Clinical Trials Register

Learn more about this trial

Comparison of rhBSSL With Placebo When Added to Infant Formula or Pasteurized Breast Milk During 4 Weeks of Treatment in Preterm Infants

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