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Growth of Infants Fed an Extensively Hydrolyzed Infant Formula

This study is currently recruiting participants.
Verified May 2013 by Nestlé
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01210391
First received: September 27, 2010
Last updated: May 15, 2013
Last verified: May 2013
History of Changes

September 27, 2010
May 15, 2013
November 2010
July 2013   (final data collection date for primary outcome measure)
Weight Gain [ Time Frame: 4 Months ] [ Designated as safety issue: No ]
Mean weight gain (g/day) from enrollment to 4 months of age.
Same as current
Complete list of historical versions of study NCT01210391 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Growth of Infants Fed an Extensively Hydrolyzed Infant Formula
Assessment of Growth of Infants Fed a 100% Whey Extensively Hydrolyzed Formula.

The primary objective of the clinical trial is to compare growth in infants (expressed as weight gain in g/day) consuming a new extensively hydrolyzed formula (EHF) to infants consuming a commercially available EHF.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Growth
  • Other: Extensively hydrolyzed whey infant formula
    New hydrolyzed infant formula.
    Other Name: Baby Formula
  • Other: Extensively hydrolyzed casein infant formula
    Commercially available infant formula.
    Other Name: Baby Formula
  • Experimental: New hydrolyzed infant formula
    New, extensively hydrolyzed infant formula
    Intervention: Other: Extensively hydrolyzed whey infant formula
  • Active Comparator: Commercially available infant formula
    Commercially available, extensively hydrolyzed infant formula.
    Intervention: Other: Extensively hydrolyzed casein infant formula
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
112
July 2013
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy newborn singleton infant
  • Full-term (>= 37 weeks gestation)
  • Birth weight between >= 2500 and < =4500 g
  • 14 ± 3 days of age on enrollment
  • Infant's mother has elected not to breastfeed
  • baby has been exclusively formula fed a minimum of 3 days prior to enrollment
  • Study explained and written information provided with Parent/Caregiver
  • Informed consent signed (parent/legal representative)

Exclusion Criteria:

  • Congenital illness or malformation affecting infant feeding and/or 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 IV antibiotic therapy in the 10 days prior to enrollment
  • Infant receiving prescription medication (with exception of topical antibiotics and/or treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements
  • Infant has received probiotics in the seven days prior to enrollment
  • Infant currently participating in another clinical study
  • Infant's family who in the Investigator's assessment cannot be expected to comply with the protocol
Both
up to 4 Months
Yes
Contact: Terri Voss +1 (973) 593-7779 terri.voss@rd.nestle.com
United States
 
NCT01210391
09.43.PED
No
Nestlé
Nestlé
Not Provided
Principal Investigator: Ricardo Sorensen, MD Louisiana State University Health Sciences Center in New Orleans
Nestlé
May 2013

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