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Growth of Infants Fed an Extensively Hydrolyzed Infant Formula

Not Applicable
Completed
Conditions
Growth
Registration Number
NCT01210391
Lead Sponsor
Société des Produits Nestlé (SPN)
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
282
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Weight Gain4 Months

Mean weight gain (g/day) from enrollment to 4 months of age.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (19)

Colorado Springs Health Partners

🇺🇸

Colorado Springs, Colorado, United States

Pedia Research

🇺🇸

Owensboro, Kentucky, United States

ARK-LA-Tex Pediatric Research

🇺🇸

Bossier City, Louisiana, United States

The Clinical Trials Center

🇺🇸

New Orleans, Louisiana, United States

Clinical Research of Nevada

🇺🇸

Las Vegas, Nevada, United States

Institute of Clinical Research

🇺🇸

Mayfield Heights, Ohio, United States

University of Oklahoma Health Sciences Center

🇺🇸

Oklahoma City, Oklahoma, United States

Cyn3rgy Research

🇺🇸

Gresham, Oregon, United States

Square-1 Clinical Research

🇺🇸

Erie, Pennsylvania, United States

Alpha Clinical Research

🇺🇸

Clarksville, Tennessee, United States

Scroll for more (9 remaining)
Colorado Springs Health Partners
🇺🇸Colorado Springs, Colorado, United States

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