Growth of Infants Fed New Starter Formula

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01079208
First received: March 2, 2010
Last updated: October 29, 2013
Last verified: October 2013

March 2, 2010
October 29, 2013
March 2010
March 2014   (final data collection date for primary outcome measure)
Weight gain will be assessed in grams per day, in the period of 14 to 112 days of life (4 months) [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01079208 on ClinicalTrials.gov Archive Site
Tolerance, morbidity, protein status, metabolic markers [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Growth of Infants Fed New Starter Formula
Assessment of Growth of Infants Fed Starter Formulas With Modified Protein and Synbiotics

The purpose of this study is to assess the growth of infants fed a novel starter formula containing synbiotics and different protein levels, compared to a standard starter infant formula, during the first four months of life.

Breastfeeding represents the "gold standard" for infant health, and efforts are being made to support breast feeding at both the international and local levels. After breast milk, infant formulas are the next best source of nutrition for newborn and growing infants. Science and industry are striving to develop formulas that mimic as close as possible the physiological responses to human milk. There are a multitude of factors that make human milk the physiologically ideal for the infant. Among these, two important factors are the level of protein and the presence of pre-and probiotics in breast milk.

The purpose of this study will be to evaluate growth of healthy infants fed a partially hydrolyzed whey protein formula with a level of protein closer to breast milk, with or without synbiotics, during the first four months of life as compared to the growth of infants fed a partially hydrolyzed whey protein formula with a standard protein level (standard formula). Additionally, the infant's digestive tolerance of the starter formula and frequency of morbidity will be investigated until 6 months of age.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Dietary Intervention
  • Other: test starter infant formula
    infants are fed for 6 months with this starter formula
  • Other: test starter infant formula with synbiotics
    infant are fed for 6 months with this formula
  • Other: control standard formula
    infant are fed 6 months with this formula
  • Placebo Comparator: standard starter infant formula
    standard starter infant formula
    Intervention: Other: control standard formula
  • Experimental: test starter formula
    test infant formula
    Intervention: Other: test starter infant formula
  • Experimental: test starter formula with synbiotics
    starter formula with synbiotics and adapted protein levels
    Intervention: Other: test starter infant formula with synbiotics
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
297
May 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy newborn infant
  • Full-term (> 37 weeks gestation)
  • Birth weight > 2500 and < 4500 g
  • 14±3 days of age on enrollment
  • Singleton birth
  • Infant's mother has elected not to breastfeed prior to enrollment
  • Has not received solid foods
  • Having obtained his/her legal representative's informed consent

Exclusion Criteria:

  • Known or suspected cow-milk allergy
  • Congenital illness or malformation that may affect infant feeding and/or growth
  • Significant prenatal and/or postnatal disease
  • Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment
  • Receiving prescription medication (with exception of treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements
  • Has received oral or intravenous antibiotic therapy in the last 7 days
  • Has received probiotics in the last 7 days
  • Currently participating in another clinical study
  • Infant's family who in the Investigator's assessment cannot be expected to comply with treatment (feeding regimen)
Both
up to 6 Months
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01079208
09.04.INF
No
Nestlé
Nestlé
Not Provided
Principal Investigator: Michael Cabana, MD, MPH Institute for Health Policy Studies, University of California
Nestlé
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP