PrematurityNCT01379417
Probiotics Supplementation in Premature Infants
A study testing Probiotic supplementation in people with Prematurity, run by Société des Produits Nestlé (SPN) at 3 sites in France.
Trial summary
The main objective is to assess the nutritional benefit of probiotics supplementation on premature infants growth. As secondary objectives, different parameters related to probiotics tolerance will be measured. Read more about this study
- Who is it for?
- Ages 1 day to 8 days
- Conditions the study is for
- Prematurity
- What is being tested?
- Probiotic supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 199 participants
- Where
- 3 sitesFrance
- Study dates
- Nov 2007to Sep 2010
- 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 1 day to 8 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age between 26 weeks and 31 weeks
- Birth weight between 700 to 1600 g
- Eutrophic infants (weight between -2 to 2 DS, Usher curves)
- Admitted to one of the participating hospital unit within the 8 days following the birth, the birth date equals the 1st day of life.
- Still on parenteral feeding or infusion on the 5th day of birth
- Non inclusion criteria
Show all 12Show fewer
- Digestive disorders > or equal to 1b on Bell stage
- Severe intra-ventricular haemorrhage (stage 3-4) before 5th day of life.
- Severe malformations or digestive malformations
- No antenatal corticosteroid therapy
- Severe medical or surgical disorder affecting the absorption, digesting and as a result the growth (Hirschsprung disease, lactose intolerance, cow milk protein allergy, mucoviscidosis).
- Parents geographical distance preventing the hospitalization follow-up in the hospital participating unit (geographical distance planned before the infant reaches 1500 g or 32 weeks of gestational age)
Who cannot join
- Enteral/Oral feeding termination during more than 72 hours due to severe digestive disorders (> or equal to 2a on Bell stage )
- Serious digestive surgery
Trial locations and contacts
3 sites in 1 country.
France3 sites
Service de Nénatologie, Hôpital Femme Mère Enfant
Bron, 69678
Service de Réanimation Néonatale et Néonatologie, Hôpital de la Croix Rousse
Lyon, 69317
Service de Réanimation Néonatale, Hôpital Arnaud de Villeneuve
Montpellier, 34295
About this study
Official title: Probiotics Supplementation and Nutritional Benefit in Premature Infants
The main objective is to assess the nutritional benefit of probiotics supplementation on premature infants growth. As secondary objectives, different parameters related to probiotics tolerance will be measured.
- Conditions
- Prematurity
- Being tested
- Probiotic supplementation
- Keywords
- Prematurity, Nutrition, Growth
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic supplementationDietary supplement
1 capsule per day, from inclusion to 4 or 6 weeks after inclusion
| Study group | Role | What they receive |
|---|---|---|
| Maltodextrin | Placebo comparator | Maltodextrin Receives: Dietary Supplement: Probiotic supplementation |
| Probiotic B lactis/B longum | Active comparator | Bifidobacterium lactis + Bifidobacterium longum Receives: Dietary Supplement: Probiotic supplementation |
| Probiotic B longum | Active comparator | Bifidobacterium longum Receives: Dietary Supplement: Probiotic supplementation |
| Probiotic B lactis | Active comparator | Bifidobacterium lactis Receives: Dietary Supplement: Probiotic supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight (g)
Measured: From 4 to 6 weeks after inclusion
Secondary outcomes (1)
Growth
measured by:
- weight gain (g/day)
- height (cm/week)
- head circumference(cm/week)
Measured: between inclusion date and 4 to 6 weeks after inclusion (= end of supplementation period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startNov 2007
- Primary completionSep 2010
- Study completionSep 2010
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 PrematurityStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Charles Picaud, Pr, Principal investigator, Hôpital de la Croix-Rousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379417
- Sponsor's protocol ID
- 04.01.FR.INF
- Other IDs
- 2006-A00062-49
- Status last verified
- Aug 2011
- First submitted
- 10 May 2011
- Last updated
- 29 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Hays S, Jacquot A, Gauthier H, Kempf C, Beissel A, Pidoux O, Jumas-Bilak E, Decullier E, Lachambre E, Beck L, Cambonie G, Putet G, Claris O, Picaud JC. Probiotics and growth in preterm infants: A randomized controlled trial, PREMAPRO study. Clin Nutr. 2016 Aug;35(4):802-11. doi: 10.1016/j.clnu.2015.06.006. Epub 2015 Jul 16.
PubMed 26220763
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics Supplementation and Nutritional Benefit in Premature Infants
- ClinicalTrials.gov ID
- NCT01379417
- Acronym / sponsor ID
- 04.01.FR.INF
- Conditions
- Prematurity
- Keywords
- Prematurity, Nutrition, Growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 23 Jun 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 main objective is to assess the nutritional benefit of probiotics supplementation on premature infants growth. As secondary objectives, different parameters related to probiotics tolerance will be measured.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Maltodextrin | Placebo comparator | Dietary Supplement: Probiotic supplementationMaltodextrin |
| Probiotic B lactis/B longum | Active comparator | Dietary Supplement: Probiotic supplementationBifidobacterium lactis + Bifidobacterium longum |
| Probiotic B longum | Active comparator | Dietary Supplement: Probiotic supplementationBifidobacterium longum |
| Probiotic B lactis | Active comparator | Dietary Supplement: Probiotic supplementationBifidobacterium lactis |
Who may qualify
- Ages
- 1 day to 8 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Gestational age between 26 weeks and 31 weeks
- Birth weight between 700 to 1600 g
- Eutrophic infants (weight between -2 to 2 DS, Usher curves)
- Admitted to one of the participating hospital unit within the 8 days following the birth, the birth date equals the 1st day of life.
- Still on parenteral feeding or infusion on the 5th day of birth
Key exclusion criteria (2 listed)
- Enteral/Oral feeding termination during more than 72 hours due to severe digestive disorders (> or equal to 2a on Bell stage )
- Serious digestive surgery
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 |
|---|---|---|
| Probiotic supplementation1 capsule per day, from inclusion to 4 or 6 weeks after inclusion | Dietary supplement | Maltodextrin, Probiotic B lactis, Probiotic B lactis/B longum, Probiotic B longum |
Primary outcome
Weight (g)
Time frame: From 4 to 6 weeks after inclusion
1 secondary outcome
Growth
Time frame: between inclusion date and 4 to 6 weeks after inclusion (= end of supplementation period)
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 29 Aug 2011.
- Derived from this study: PubMed 26220763Hays S, Jacquot A, Gauthier H, Kempf C, Beissel A, Pidoux O, Jumas-Bilak E, Decullier E, Lachambre E, Beck L, Cambonie G, Putet G, Claris O, Picaud JC. Probiotics and growth in preterm infants: A randomized controlled trial, PREMAPRO study. Clin Nutr. 2016 Aug;35(4):802-11. doi: 10.1016/j.clnu.2015.06.006. Epub 2015 Jul 16.
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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.
Jean-Charles Picaud, Pr principal investigator
Hôpital de la Croix-Rousse
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic supplementation in people with Prematurity, run by Société des Produits Nestlé (SPN) at 3 sites in France.
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 12 inclusion and 2 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 29 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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.
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?
Weight (g) (time frame: From 4 to 6 weeks after inclusion). 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 NCT01379417, 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 29 Aug 2011.