Replacement Therapy in Preterm InfantsPhase 2NCT00658905
Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Infant Formula for Preterm Infants
A Phase 2 study testing rhBSSL in people with Replacement Therapy in Preterm Infants, run by Swedish Orphan Biovitrum at 6 sites in Italy.
Trial summary
The purpose of this study is to evaluate the efficacy in preterm infants following treatment with BSSL when administered in infant formula. Read more about this study
- Who is it for?
- Ages Up to 32 weeks
- Conditions the study is for
- Replacement Therapy in Preterm Infants
- What is being tested?
- rhBSSL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 6 sitesItaly
- Study dates
- Apr 2008to May 2009
- Phase
- Phase 2
- 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 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants
- less than or equal to 32 weeks of gestational age
- appropriate for gestational age
- enterally fed with infant formula
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites
Presidio Ospedaliero di Alta Specializzazione G.Salesi Azienda Ospedaliero Universitaria Ospedali Riuniti "Umberto I-G.M.Lancisi -G.Salesi
Ancona
Azienda Ospedaliera "Ospedale Policlinico Consorziale",U.O Neonatologia e Terapia Intensiva Neonatale
Bari
3) U.O. di Neonatologia e Terapia Intensiva Neonatale Università degli Studi di Milano, Ospedale Maggiore Policlinico,Mangiagalli e Regina Elena-Fondazione IRCCS
Milan
4) Policlinico Universitario-Azienda Ospedaliera di Padova, Dipartimento di Pediatria
Padova
Clinical Pediatrica-Neonatologia, Policlinico Gemelli, Universita Cattolica
Rome
U.O. Neonatologia, Patologia Neonatale e Terapia Intensiva
Rome
About this study
Official title: A Prospective, Randomized, Double-blind Crossover Study Comparing 0.15 g/L rhBSSL Added to Infant Formula Versus Placebo During One Week of Treatment in Preterm Infants Born Before Week 32 of Gestational Age
The purpose of this study is to evaluate the efficacy in preterm infants following treatment with BSSL when administered in infant formula.
Read the detailed description
In this double-blind crossover study, patients will be randomized to receive infant formula including BSSL or infant formula without BSSL for the first 7 days. After a wash-out period of 2 days the patients will "crossover" to the other treatment regimen and receive an additional 7 days treatment. The primary efficacy measurements will be made by collecting stool during the last three days of each treatment period.
- Conditions
- Replacement Therapy in Preterm Infants
- Being tested
- rhBSSL, Placebo
- Keywords
- Preterm infants, Replacement therapy, Infant formula, BSSL, BSSL is present in fresh mother's milk but not in infant formula.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhBSSLDrug
Also called bucelipase alfa (INN)
0.15 g/L rhBSSL added to infant formula; one week treatment
PlaceboDrug
One week treatment
| Study group | Role | What they receive |
|---|---|---|
| rhBSSL | Active comparator | Not described Receives: Drug: rhBSSL |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coefficient of Fat Absorption in stool
Measured: 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 between the start and end of each treatment period
Measured: Baseline and after one week of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Replacement Therapy in Preterm InfantsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 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, Biovitrum AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00658905
- Sponsor's protocol ID
- BVT.BSSL-020
- Status last verified
- Oct 2014
- First submitted
- 14 Apr 2008
- Last updated
- 3 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25222806
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blind Crossover Study Comparing 0.15 g/L rhBSSL Added to Infant Formula Versus Placebo During One Week of Treatment in Preterm Infants Born Before Week 32 of Gestational Age
- ClinicalTrials.gov ID
- NCT00658905
- Acronym / sponsor ID
- BVT.BSSL-020
- Conditions
- Replacement Therapy in Preterm Infants
- Keywords
- Preterm infants, Replacement therapy, Infant formula, BSSL, BSSL is present in fresh mother's milk but not in infant formula.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Swedish Orphan BiovitrumIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 16 Apr 2008 (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 evaluate the efficacy in preterm infants following treatment with BSSL when administered in infant formula.
Detailed description
In this double-blind crossover study, patients will be randomized to receive infant formula including BSSL or infant formula without BSSL for the first 7 days. After a wash-out period of 2 days the patients will "crossover" to the other treatment regimen and receive an additional 7 days treatment. The primary efficacy measurements will be made by collecting stool during the last three days of each treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rhBSSL | Active comparator | Drug: rhBSSL |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- Up to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Preterm infants
- less than or equal to 32 weeks of gestational age
- appropriate for gestational age
- enterally fed with infant formula
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| rhBSSLAlso: bucelipase alfa (INN)0.15 g/L rhBSSL added to infant formula; one week treatment | Drug | rhBSSL |
| PlaceboOne week treatment | Drug | Placebo |
Primary outcome
Coefficient of Fat Absorption in stool
Time frame: Stool collected for a 72-hour period during the final 3 days of each treatment period
1 secondary outcome
Change in length and body weight between the start and end of each treatment period
Time frame: Baseline and after one week of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2014.
- 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.
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
Biovitrum AB
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rhBSSL in people with Replacement Therapy in Preterm Infants, run by Swedish Orphan Biovitrum at 6 sites in Italy.
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 4 inclusion and 0 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: finished, as of the sponsor's last update on 3 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Coefficient of Fat Absorption in stool (time frame: Stool collected for a 72-hour period during the final 3 days of each treatment period). 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 NCT00658905, which also lists 1 linked publication.
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 3 Nov 2014.