Effects on Growth of an Extensively Hydrolyzed Formula Fed to Term

Perrigo

Status: Completed

Conditions: Growth

Treatments: Other: Extensively hydrolyzed infant formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT00936637

UVA Growth Study

Details and patient eligibility

About

The purpose of this study is to assess growth in infants who are fed an extensively hydrolyzed formula.

Enrollment: 35 patients

Sex: All

Ages: 1 to 21 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• At birth:

  • Healthy, term (37-42 weeks) infant
  • Weight for length between the 10th and 90th percentile according to the National Center for Health Statistics (NCHS) growth charts

• At time of enrollment:

  • < or = 21 days post-natal age
  • Weight for length between the 10th and 90th percentile according to the National Center for Health Statistics (NCHS) growth charts
  • Exclusively formula fed
  • Written informed consent of parent/guardian

Exclusion criteria

• At the time of enrollment: partially human-milk fed; fed baby/solid foods
• Conditions requiring feedings other than those specified in the protocol
• Documented or suspected cow's milk allergy and/or soy protein allergies
• Major congenital deformities
• Suspected or documented systemic or congenital infections
• Evidence of cardiac, respiratory, hematological, gastrointestinal, or other systemic diseases
• Participation in any other clinical trial

Trial design

35 participants in 1 patient group

Extensively hydrolyzed infant formula

Experimental group

Treatment:

Other: Extensively hydrolyzed infant formula