Preterm InfantsNCT01330095
Early Administration of Bifidobacterium to Very Low Birth Weight Infants
A study testing Administration of Bifidobacterium bifidum in people with Preterm Infants, run by Tokyo Women's Medical University at 1 site in Japan.
Trial summary
To evaluate the effects of early administration of probiotics on acceleration of enteral feeding, and on growth of very low birth weight infants, newborn infants with birth weight less than 1500g are administered Bifidobacterium bifidum twice a day. Read more about this study
- Who is it for?
- Ages Up to 7 days
- Conditions the study is for
- Preterm Infants
- What is being tested?
- Administration of Bifidobacterium bifidum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2007to Dec 2008
- Phase
- Interventional
- 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 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Very low birth weight infant
Who cannot join
- Presence of major congenital malformations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Administration of Bifidobacterium Bifidum to Very Low Birth Weight Infants: A Pilot Study
To evaluate the effects of early administration of probiotics on acceleration of enteral feeding, and on growth of very low birth weight infants, newborn infants with birth weight less than 1500g are administered Bifidobacterium bifidum twice a day.
- Conditions
- Preterm Infants
- Being tested
- Administration of Bifidobacterium bifidum
- Keywords
- Bifidobacterium bifidum, Very low birth weight infant, Enteral feeding, Growth, amount of enteral feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of Bifidobacterium bifidumDietary supplement
Also called Bifidobacterium bifidum OLB6378
Administration of Bifidobacterium bifidum to very low birth weight infants
| Study group | Role | What they receive |
|---|---|---|
| Eearly administration | Active comparator | Administration of Bifidobacterium within 48h after birth Receives: Dietary Supplement: Administration of Bifidobacterium bifidum |
| Late administration | Active comparator | Administration of Bifidobacterium more than 48h after birth Receives: Dietary Supplement: Administration of Bifidobacterium bifidum |
What is being measured
The primary outcome is the main question the study is designed to answer.
the day at total feeding volume reached 100ml/kg/day
the post natal day at total enteral feeding reached 100ml/kg/day
Measured: post natal day
Secondary outcomes (1)
colonizatin of Bifidobacterium
the level of Bifidobacterium in feces from the study infants growth rate of the study infants the positive rate of MRSA colonization among the study infants adverse outcomes
Measured: 4 weeks after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startMar 2007
- Primary completionJun 2008
- Study completionDec 2008
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 Preterm InfantsStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokyo Women's Medical University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330095
- Sponsor's protocol ID
- 1016
- Other IDs
- UMIN000005245
- Status last verified
- Dec 2008
- First submitted
- 1 Apr 2011
- Last updated
- 6 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Yamasaki C, Totsu S, Uchiyama A, Nakanishi H, Masumoto K, Washio Y, Shuri K, Ishida S, Imai K, Kusuda S. Effect of Bifidobacterium administration on very-low-birthweight infants. Pediatr Int. 2012 Oct;54(5):651-6. doi: 10.1111/j.1442-200X.2012.03649.x. Epub 2012 Jul 10.
PubMed 22507386
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Administration of Bifidobacterium Bifidum to Very Low Birth Weight Infants: A Pilot Study
- ClinicalTrials.gov ID
- NCT01330095
- Acronym / sponsor ID
- 1016
- Conditions
- Preterm Infants
- Keywords
- Bifidobacterium bifidum, Very low birth weight infant, Enteral feeding, Growth, amount of enteral feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Tokyo Women's Medical UniversityUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 6 Apr 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.
To evaluate the effects of early administration of probiotics on acceleration of enteral feeding, and on growth of very low birth weight infants, newborn infants with birth weight less than 1500g are administered Bifidobacterium bifidum twice a day.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eearly administration | Active comparator | Dietary Supplement: Administration of Bifidobacterium bifidumAdministration of Bifidobacterium within 48h after birth |
| Late administration | Active comparator | Dietary Supplement: Administration of Bifidobacterium bifidumAdministration of Bifidobacterium more than 48h after birth |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Very low birth weight infant
Key exclusion criteria (1 listed)
- Presence of major congenital malformations
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 |
|---|---|---|
| Administration of Bifidobacterium bifidumAlso: Bifidobacterium bifidum OLB6378Administration of Bifidobacterium bifidum to very low birth weight infants | Dietary supplement | Eearly administration, Late administration |
Primary outcome
the day at total feeding volume reached 100ml/kg/day
Time frame: post natal day
the post natal day at total enteral feeding reached 100ml/kg/day
1 secondary outcome
colonizatin of Bifidobacterium
Time frame: 4 weeks after birth
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 6 Apr 2011.
- Derived from this study: PubMed 22507386Yamasaki C, Totsu S, Uchiyama A, Nakanishi H, Masumoto K, Washio Y, Shuri K, Ishida S, Imai K, Kusuda S. Effect of Bifidobacterium administration on very-low-birthweight infants. Pediatr Int. 2012 Oct;54(5):651-6. doi: 10.1111/j.1442-200X.2012.03649.x. Epub 2012 Jul 10.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Administration of Bifidobacterium bifidum in people with Preterm Infants, run by Tokyo Women's Medical University at 1 site in Japan.
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 1 inclusion and 1 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 6 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
the day at total feeding volume reached 100ml/kg/day (time frame: post natal day). 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 NCT01330095, 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 6 Apr 2011.