Assessment of Growth of Infants Fed a New Formula
This study is ongoing, but not recruiting participants.
Sponsor:
Nestlé
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT00937014
First received: July 9, 2009
Last updated: January 16, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Infant Nutrition |
Other: standard infant formula Other: Test formula |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) |
| Official Title: | Assessment of Growth of Infants Fed a Starter Formula With a Whey-Isolate Enriched in Lactoferrin |
Resource links provided by NLM:
Further study details as provided by Nestlé:
Primary Outcome Measures:
- Mean weight gain [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- anthropometry, tolerance, morbidity, blood tests [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 140 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Standard infant formula |
Other: standard infant formula
Standard infant formula given during the first 9 months of life, as per standard requirement
|
| Experimental: Test formula |
Other: Test formula
Test formula enriched in lactoferrin given during the first 9 months of life, as per standard requirement.
|
Eligibility| Ages Eligible for Study: | up to 17 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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
- Informed consent signed (Parent/Legal representative)
- Parent/Caregiver has a working freezer
- Lives within 45 minutes of a study site
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00937014
Locations
| United States, Indiana | |
| Pedia Research, LLC | |
| Newburgh, Indiana, United States, 47630 | |
| United States, Kentucky | |
| Pedia Research, LLC | |
| Owensboro, Kentucky, United States, 42301 | |
| United States, Maryland | |
| University of Maryland School of Medicine | |
| Baltimore, Maryland, United States, 21201 | |
Sponsors and Collaborators
Nestlé
Investigators
| Principal Investigator: | Susan Feigelman, MD | University of Maryland School of Medicine, Department of Pediatrics |
More Information
No publications provided
| Responsible Party: | Nestlé |
| ClinicalTrials.gov Identifier: | NCT00937014 History of Changes |
| Other Study ID Numbers: | 07.35.INF |
| Study First Received: | July 9, 2009 |
| Last Updated: | January 16, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Nestlé:
|
infant formula growth weight |
ClinicalTrials.gov processed this record on May 19, 2013