Infant NutritionNCT00984230
A New Adaptive Feeding Plan for Newborns
A study testing BSF, BSF + Lactoferrin + Probiotics and BSF + Lactoferrin + Probiotics + OS in people with Infant Nutrition, run by Société des Produits Nestlé (SPN) at 6 sites in 3 countries.
Trial summary
The purpose of this clinical trial is to identify the infant formula(s) for which the investigators get the closest gut maturation index compared to the one they get with breastfed babies. Read more about this study
- Who is it for?
- Ages 1 day to 3 daysHealthy volunteers can take part
- Conditions the study is for
- Infant Nutrition
- What is being tested?
- BSF, BSF + Lactoferrin + Probiotics and BSF + Lactoferrin + Probiotics + OS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Sep 2009to Feb 2011
- 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 3 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy newborn infant
- Full term infant (≥ 37 weeks gestation; < 42 weeks gestation)
- Birth weight from 2500g to 4500g
- For the formula-fed groups: babies whose mothers elected not to breastfeed at all
- For the breastfed group: babies whose mothers elected to exclusively breastfeed for at least 2 months
- Newborn whose parents / caregivers can be expected to comply with the protocol
- Study explained and written information given
- Informed consent signed
Who cannot join
- Mother who had antibiotics in the 7 days preceding delivery
- Caesarian section
- Multiple birth
- Congenital illness or malformation that may affect normal growth
- Significant pre-natal and/or post-natal disease
- Newborn participating in another clinical trial
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
France4 sites
Service de Réanimation Néonatale et Néonatologie, Hôpital de la Croix Rousse
Lyon, 69317
Maternité Régionale, Service de Néonatologie
Nancy, 54042
Service de Néonatologie
Nantes, 44093
Hôpital Charles Nicolle, Département de Pédiatrie
Rouen, 76031
Greece1 site
Alexandra Regional General Hospital, Department of Neonatology
Palaió Fáliro, Athens, 17562
About this study
Official title: A New Adaptive Feeding Plan for Newborns: Effects on Gut Maturity and Gut Microbiota
The purpose of this clinical trial is to identify the infant formula(s) for which the investigators get the closest gut maturation index compared to the one they get with breastfed babies.
- Conditions
- Infant Nutrition
- Being tested
- BSF, BSF + Lactoferrin + Probiotics, BSF + Lactoferrin + Probiotics + OS
- Keywords
- Infant Formula, Gut
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BSFOther
feeding amount according to individual baby need
BSF + Lactoferrin + ProbioticsOther
feeding amount according to individual baby need
BSF + Lactoferrin + Probiotics + OSOther
feeding amount according to individual baby need
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding (Reference) | No intervention | Not described |
| Basic starter formula: BSF | Active comparator | Not described Receives: Other: BSF |
| BSF + Lactoferrin + Probiotics + OS | Experimental | Not described Receives: Other: BSF + Lactoferrin + Probiotics + OS |
| BSF + Lactoferrin + Probiotics | Experimental | Not described Receives: Other: BSF + Lactoferrin + Probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
gut maturation : Specific proteins in stools
Measured: 3rd day, at 1 week, 2 weeks and 1 month of age
Secondary outcomes (1)
Growth and gut microbiota
Measured: At 1 month and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionJan 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant NutritionStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Charles Pr Picaud, Principal investigator, Service de Réanimation Néonatale et Néonatologie, Hôpital de la Croix Rousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984230
- Sponsor's protocol ID
- 07.22.INF
- Status last verified
- Jun 2013
- First submitted
- 10 Sep 2009
- Last updated
- 5 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Adaptive Feeding Plan for Newborns: Effects on Gut Maturity and Gut Microbiota
- ClinicalTrials.gov ID
- NCT00984230
- Acronym / sponsor ID
- 07.22.INF
- Conditions
- Infant Nutrition
- Keywords
- Infant Formula, Gut
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 25 Sep 2009 (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 clinical trial is to identify the infant formula(s) for which the investigators get the closest gut maturation index compared to the one they get with breastfed babies.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding (Reference) | No intervention | – |
| Basic starter formula: BSF | Active comparator | Other: BSF |
| BSF + Lactoferrin + Probiotics + OS | Experimental | Other: BSF + Lactoferrin + Probiotics + OS |
| BSF + Lactoferrin + Probiotics | Experimental | Other: BSF + Lactoferrin + Probiotics |
Who may qualify
- Ages
- 1 day to 3 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Healthy newborn infant
- Full term infant (≥ 37 weeks gestation; < 42 weeks gestation)
- Birth weight from 2500g to 4500g
- For the formula-fed groups: babies whose mothers elected not to breastfeed at all
- For the breastfed group: babies whose mothers elected to exclusively breastfeed for at least 2 months
Key exclusion criteria (6 listed)
- Mother who had antibiotics in the 7 days preceding delivery
- Caesarian section
- Multiple birth
- Congenital illness or malformation that may affect normal growth
- Significant pre-natal and/or post-natal disease
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 |
|---|---|---|
| BSFfeeding amount according to individual baby need | Other | Basic starter formula: BSF |
| BSF + Lactoferrin + Probioticsfeeding amount according to individual baby need | Other | BSF + Lactoferrin + Probiotics |
| BSF + Lactoferrin + Probiotics + OSfeeding amount according to individual baby need | Other | BSF + Lactoferrin + Probiotics + OS |
Primary outcome
gut maturation : Specific proteins in stools
Time frame: 3rd day, at 1 week, 2 weeks and 1 month of age
1 secondary outcome
Growth and gut microbiota
Time frame: At 1 month and 2 months
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 5 Jun 2013.
Related trials for Infant Nutrition
RecruitingObservational study
Hospital-Based Prospective Cohort of Malnutrition Under 6-Month Study (HOSPIC-6-Study)
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Climate-Responsive Nutrition, WASH, and Heat Counselling for Maternal and Child Health in Sindh, Pakistan
Maternal Nutrition, Child Nutrition
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Healthy for my Baby- RCT of a Lifestyle Intervention for Overweight Women in Preconception
Overweight and Obesity, Pregnancy Complications
Not yet recruiting
Short-Term Enteral Nutrition for Infants With Bronchiolitis in Pediatric Emergency Departments
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RecruitingPhase 4
Impact of Higher Zinc Supplementation on Neonatal Weight Velocity
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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 Pr Picaud principal investigator
Service de Réanimation Néonatale et Néonatologie, Hôpital de la Croix Rousse
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BSF, BSF + Lactoferrin + Probiotics and BSF + Lactoferrin + Probiotics + OS in people with Infant Nutrition, run by Société des Produits Nestlé (SPN) at 6 sites in 3 countries.
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 8 inclusion and 6 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 5 Jun 2013. 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 France, Austria, Greece. 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?
gut maturation : Specific proteins in stools (time frame: 3rd day, at 1 week, 2 weeks and 1 month of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2013.