Infant NutritionNCT00937014
Assessment of Growth of Infants Fed a New Formula
A study testing standard infant formula and Test formula in people with Infant Nutrition, run by Société des Produits Nestlé (SPN) at 3 sites in United States.
Trial summary
The purpose of this clinical trial is to assess growth (rate of weight gain in grams per day) of infants fed an infant formula with a whey isolate enriched with lactoferrin, during the first four months of life as compared to infants fed a standard infant formula. Read more about this study
- Who is it for?
- Ages 11 to 17 daysHealthy volunteers can take part
- Conditions the study is for
- Infant Nutrition
- What is being tested?
- standard infant formula and Test formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2010to Jun 2013
- 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 11 to 17 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy newborn infant
- Full-term (>37 weeks gestation)
- Birth weight between > 2500 and < 4500 g
- Infant's mother has elected not to breastfeed and baby has been exclusively formula fed a minimum 3 days prior to enrollment
- Tolerating a cows milk based formula for at least 3 days
- Study explained and written information provided with Parent/Caregiver demonstrating understanding of the given information
Show all 9Show fewer
- Informed consent signed (Parent/Legal representative)
- Parent/Caregiver has a working freezer
- Lives within 45 minutes of a study site
Who cannot join
- Congenital illness or malformation that may affect infant feeding and/or normal growth
- Suspected or known allergy to cow's milk protein
- Significant pre-natal and/or post-natal disease
- Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment
- Infant has received oral or intravenous antibiotic therapy in the 10 days prior to enrollment
- Infant receiving prescription medication (with exception of treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements
- Infant currently participating in another clinical study
- Infant's family who in the Investigator's assessment cannot be expected to comply with the protocol
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Maryland School of Medicine
Baltimore, Maryland, 21201
Pedia Research, LLC
Newburgh, Indiana, 47630
Pedia Research, LLC
Owensboro, Kentucky, 42301
About this study
Official title: Assessment of Growth of Infants Fed a Starter Formula With a Whey-Isolate Enriched in Lactoferrin
The purpose of this clinical trial is to assess growth (rate of weight gain in grams per day) of infants fed an infant formula with a whey isolate enriched with lactoferrin, during the first four months of life as compared to infants fed a standard infant formula.
- Conditions
- Infant Nutrition
- Being tested
- standard infant formula, Test formula
- Keywords
- infant formula, growth, weight
- Medical subject headings
- Body Weight
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 given during the first 9 months of life, as per standard requirement
Test formulaOther
Test formula enriched in lactoferrin given during the first 9 months of life, as per standard requirement.
| Study group | Role | What they receive |
|---|---|---|
| Standard infant formula | Active comparator | Not described Receives: Other: standard infant formula |
| Test formula | Experimental | Not described Receives: Other: Test formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean weight gain
Measured: 4 months
Secondary outcomes (1)
anthropometry, tolerance, morbidity, blood tests
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2009 (estimated)
- Study startFeb 2010
- Primary completionJun 2013
- Study completionJun 2013
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.
- 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susan Feigelman, MD, Principal investigator, University of Maryland School of Medicine, Department of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00937014
- Sponsor's protocol ID
- 07.35.INF
- Status last verified
- Jun 2013
- First submitted
- 9 Jul 2009
- Last updated
- 26 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Growth of Infants Fed a Starter Formula With a Whey-Isolate Enriched in Lactoferrin
- ClinicalTrials.gov ID
- NCT00937014
- Acronym / sponsor ID
- 07.35.INF
- Conditions
- Infant Nutrition
- Keywords
- infant formula, growth, weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 10 Jul 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 assess growth (rate of weight gain in grams per day) of infants fed an infant formula with a whey isolate enriched with lactoferrin, during the first four months of life as compared to infants fed a standard infant formula.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard infant formula | Active comparator | Other: standard infant formula |
| Test formula | Experimental | Other: Test formula |
Who may qualify
- Ages
- 11 to 17 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Healthy newborn infant
- Full-term (>37 weeks gestation)
- Birth weight between > 2500 and < 4500 g
- Infant's mother has elected not to breastfeed and baby has been exclusively formula fed a minimum 3 days prior to enrollment
- Tolerating a cows milk based formula for at least 3 days
Key exclusion criteria (8 listed)
- Congenital illness or malformation that may affect infant feeding and/or normal growth
- Suspected or known allergy to cow's milk protein
- Significant pre-natal and/or post-natal disease
- Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment
- Infant has received oral or intravenous antibiotic therapy in the 10 days prior to enrollment
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 formulaStandard infant formula given during the first 9 months of life, as per standard requirement | Other | Standard infant formula |
| Test formulaTest formula enriched in lactoferrin given during the first 9 months of life, as per standard requirement. | Other | Test formula |
Primary outcome
Mean weight gain
Time frame: 4 months
1 secondary outcome
anthropometry, tolerance, morbidity, blood tests
Time frame: 9 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 26 Jun 2013.
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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.
Susan Feigelman, MD principal investigator
University of Maryland School of Medicine, Department of Pediatrics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard infant formula and Test formula in people with Infant Nutrition, run by Société des Produits Nestlé (SPN) at 3 sites in United States.
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 9 inclusion and 8 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 26 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 3 sites in United States. 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?
Mean weight gain (time frame: 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 26 Jun 2013.