Infant GrowthNCT02111837
Effects of Specific Lipid Fractions-enriched Infant Formulae
A study testing Standard infant formula, Standard infant formula with PL1 and Standard infant formula with PL2 in people with Infant Growth, run by Société des Produits Nestlé (SPN) at 4 sites in 2 countries.
Trial summary
This is a multicenter, randomized, double-blind, parallel-group, reference-controlled 4-month pilot safety study to evaluate the effects of specific lipid fractions-enriched infant formulae on growth of infants aged 0-4 months. Read more about this study
- Who is it for?
- Ages 1 day to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Infant Growth
- What is being tested?
- Standard infant formula, Standard infant formula with PL1 and Standard infant formula with PL2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 199 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Nov 2009to Dec 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 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy newborn infant
- Infant is ≤14 days old on day of enrollment
- Gestational age ≥37 weeks (full term infants)
- Birth weight ≥2500 g and ≤4500 g
- Singleton birth
- Having obtained his/her parents'/legal representative's informed consent
Who cannot join
- Having any significant pre-natal and/or post-natal disease and/or congenital illness or malformation that may affect normal growth.
- Infant undergoing antibiotic therapy.
- Re-hospitalization for more than 2 days in the first 14 days of life.
- Parents not expected to comply with the protocol during the period of study participation.
- Infants currently participating in another trial
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
France3 sites
Groupe Hospitalier Pellegrin
Bordeaux, 33076
CHU de Caen
Caen, Cedex 9, 14033
Hôpital Bretonneau - UPM
Tours, Cedex 9, 37044
About this study
Official title: Multicenter, Randomized, Double-blind, Parallel-group, Reference-controlled, Safety Pilot Study to Evaluate the Effects of Specific Lipid Fractions-enriched Infant Formulae in Infants Aged 0-4 Months
This is a multicenter, randomized, double-blind, parallel-group, reference-controlled 4-month pilot safety study to evaluate the effects of specific lipid fractions-enriched infant formulae on growth of infants aged 0-4 months. The study will test the hypothesis that growth of infants fed the specific lipid fractions-enriched infant formulae will be noninferior to growth of infants fed standard infant formula.
- Conditions
- Infant Growth
- Being tested
- Standard infant formula, Standard infant formula with PL1, Standard infant formula with PL2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard infant formulaOther
Standard infant formula with PL1Other
Standard infant formula with PL2Other
| Study group | Role | What they receive |
|---|---|---|
| Standard infant formula | Placebo comparator | Standard infant formula fed ad libitum Receives: Other: Standard infant formula |
| Standard infant formula with PL1 | Experimental | Standard infant formula enriched with PL1 lipid fraction fed ad libitum Receives: Other: Standard infant formula with PL1 |
| Standard infant formula with PL2 | Experimental | Standard infant formula enriched with PL2 lipid fraction fed ad libitum Receives: Other: Standard infant formula with PL2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean weight gain (g/day)
Measured: Enrollment to age 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startNov 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant GrowthStudies 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
- 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
- Claude Billeaud, MD, Principal investigator, Hôpital des enfants, CHU Pellegrin, Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111837
- Sponsor's protocol ID
- 07.16.INF.B
- Status last verified
- Apr 2014
- First submitted
- 9 Apr 2014
- Last updated
- 11 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-blind, Parallel-group, Reference-controlled, Safety Pilot Study to Evaluate the Effects of Specific Lipid Fractions-enriched Infant Formulae in Infants Aged 0-4 Months
- ClinicalTrials.gov ID
- NCT02111837
- Acronym / sponsor ID
- 07.16.INF.B
- Conditions
- Infant 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 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 11 Apr 2014 (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.
This is a multicenter, randomized, double-blind, parallel-group, reference-controlled 4-month pilot safety study to evaluate the effects of specific lipid fractions-enriched infant formulae on growth of infants aged 0-4 months. The study will test the hypothesis that growth of infants fed the specific lipid fractions-enriched infant formulae will be noninferior to growth of infants fed standard infant formula.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard infant formula | Placebo comparator | Other: Standard infant formulaStandard infant formula fed ad libitum |
| Standard infant formula with PL1 | Experimental | Other: Standard infant formula with PL1Standard infant formula enriched with PL1 lipid fraction fed ad libitum |
| Standard infant formula with PL2 | Experimental | Other: Standard infant formula with PL2Standard infant formula enriched with PL2 lipid fraction fed ad libitum |
Who may qualify
- Ages
- 1 day to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Healthy newborn infant
- Infant is ≤14 days old on day of enrollment
- Gestational age ≥37 weeks (full term infants)
- Birth weight ≥2500 g and ≤4500 g
- Singleton birth
Key exclusion criteria (5 listed)
- Having any significant pre-natal and/or post-natal disease and/or congenital illness or malformation that may affect normal growth.
- Infant undergoing antibiotic therapy.
- Re-hospitalization for more than 2 days in the first 14 days of life.
- Parents not expected to comply with the protocol during the period of study participation.
- Infants currently participating in another trial
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 |
|---|---|---|
| Standard infant formula | Other | Standard infant formula |
| Standard infant formula with PL1 | Other | Standard infant formula with PL1 |
| Standard infant formula with PL2 | Other | Standard infant formula with PL2 |
Primary outcome
Mean weight gain (g/day)
Time frame: Enrollment to age 4 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 11 Apr 2014.
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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.
Claude Billeaud, MD principal investigator
Hôpital des enfants, CHU Pellegrin, Bordeaux, France
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard infant formula, Standard infant formula with PL1 and Standard infant formula with PL2 in people with Infant Growth, run by Société des Produits Nestlé (SPN) at 4 sites in 2 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 6 inclusion and 5 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 11 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, 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.
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?
Mean weight gain (g/day) (time frame: Enrollment to age 4 months). 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 11 Apr 2014.