Clinical trial NCT01210391: Growth of Infants Fed an Extensively Hydrolyzed Infant Formula
Official title: Assessment of Growth of Infants Fed a 100% Whey Extensively Hydrolyzed Formula.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2010-09-28
Enrollment: 282
Sex: ALL
Minimum age (years): 11
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Weight Gain
timeFrame: 4 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Colorado Springs Health Partners
state: Colorado
city: Newburgh
country: United States
facility: Pedia Research
state: Indiana
city: Owensboro
country: United States
facility: Pedia Research
state: Kentucky
city: Bossier City
country: United States
facility: ARK-LA-Tex Pediatric Research
state: Louisiana
city: New Orleans
country: United States
facility: The Clinical Trials Center
state: Louisiana
city: Las Vegas
country: United States
facility: Clinical Research of Nevada
state: Nevada
city: Mayfield Heights
country: United States
facility: Institute of Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Gresham
country: United States
facility: Cyn3rgy Research
state: Oregon
city: Erie
country: United States
facility: Square-1 Clinical Research
state: Pennsylvania
city: Clarksville
country: United States
facility: Alpha Clinical Research
state: Tennessee
city: Jackson
country: United States
facility: Jackson Clinic
state: Tennessee
city: Austin
country: United States
facility: Scott & White Wells Branch Clinic
state: Texas
city: Killeen
country: United States
facility: Scott & White Killeen Clinic
state: Texas
city: Longview
country: United States
facility: DCOL Center for Research
state: Texas
city: San Antonio
country: United States
facility: Southwest Children's Research Associates
state: Texas
city: Temple
country: United States
facility: Scott & White Temple
state: Texas
city: Layton
country: United States
facility: Tanner Clinic
state: Utah
city: Richmond
country: United States
facility: Clinical Research Partners
state: Virginia
city: Wenatchee
country: United States
facility: Wenatchee Valley Medical Center
state: Washington
Study officials:
affiliation: Louisiana State University Health Sciences Center in New Orleans
name: Ricardo Sorensen, MD
role: PRINCIPAL_INVESTIGATOR
References: