Growth of Infants Fed an Extensively Hydrolyzed Infant Formula

Completed · Not applicable

Conditions studied: Growth

In brief

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.

Key facts

Study ID

NCT01210391

Run by

Société des Produits Nestlé (SPN)

People needed

282

Starts

2010-11-01

Expected to finish

2013-07-01

Last updated by the study team

2014-06-26

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Colorado Springs Health Partners — Colorado Springs, Colorado, United States
• Pedia Research — Newburgh, Indiana, 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
• Jackson Clinic — Jackson, Tennessee, United States
• Scott & White Wells Branch Clinic — Austin, Texas, United States
• Scott & White Killeen Clinic — Killeen, Texas, United States
• DCOL Center for Research — Longview, Texas, United States
• Southwest Children's Research Associates — San Antonio, Texas, United States
• Scott & White Temple — Temple, Texas, United States
• Tanner Clinic — Layton, Utah, United States
• Clinical Research Partners — Richmond, Virginia, United States
• Wenatchee Valley Medical Center — Wenatchee, Washington, United States

Full record on ClinicalTrials.gov

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