NCT00659243

Brief Summary

The purpose of this study is to evaluate the efficacy in preterm infants following treatment with BSSL when administered in pasteurized breast milk.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2008

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 14, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 16, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

November 3, 2014

Status Verified

October 1, 2014

Enrollment Period

1.9 years

First QC Date

April 14, 2008

Last Update Submit

October 31, 2014

Conditions

Replacement Therapy in Preterm Infants

Keywords

Replacement therapyPasteurized breast milkPreterm infantsBSSL

Outcome Measures

Primary Outcomes (1)

  • Coefficient of Fat Absorption measured in stool

    Stool collected for a 72-hour period during the final 3 days of each treatment period

Secondary Outcomes (1)

  • Change in length and body weight

    Baseline and after one week of treatment

Study Arms (2)

rhBSSL

EXPERIMENTAL
Drug: rhBSSL

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

rhBSSLDRUG

0.15 g/L rhBSSL added to pasteurized breast milk; one week treatment

Also known as: bucelipase alfa (INN)
rhBSSL
PlaceboDRUG

One week treatment

Placebo

Eligibility Criteria

AgeUp to 32 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Preterm infants
  • less than or equal to 32 weeks of gestational age
  • appropriate for gestational age
  • enterally fed with pasteurized breast milk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Hopital de la Croix Rousse

Lyon, France

Location

Hopital la Conception,

Marseille, France

Location

Maternité A. Pinard, Néonatologie

Nancy, France

Location

Hopital Saint Vincent de Paul

Paris, France

Location

Hopital des Enfants

Toulouse, France

Location

CHRU de Tours, Centre de Pédiatrie Gatien de Clocheville

Tours, France

Location

Presidio Ospedaliero di Alta Specializzazione G.Salesi Azienda Ospedaliero Universitaria Ospedali Riuniti "Umberto I-G.M. Lancisi-G.Salesi"

Ancona, Italy

Location

Policlinico Universitario-Azienda Ospedeliero di Padova, Dipartimento di Pediatria

Padua, Italy

Location

Related Publications (1)

  • 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.

    PMID: 25222806DERIVED

Study Officials

  • Kristina Timdahl, MD

    Biovitrum AB

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2008

First Posted

April 16, 2008

Study Start

March 1, 2008

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

November 3, 2014

Record last verified: 2014-10

Locations

IT(2)FR(6)