NCT00936637

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2009

Completed
Last Updated

July 10, 2009

Status Verified

July 1, 2009

Enrollment Period

1.4 years

First QC Date

July 8, 2009

Last Update Submit

July 9, 2009

Conditions

Growth

Outcome Measures

Primary Outcomes (1)

  • An extensively hydrolyzed formula is nutritionally adequate for normal growth of healthy full-term infants

    16 weeks

Study Arms (1)

Extensively hydrolyzed infant formula

EXPERIMENTAL
Other: Extensively hydrolyzed infant formula

Interventions

Extensively hydrolyzed infant formulaOTHER
Extensively hydrolyzed infant formula

Eligibility Criteria

Age1 Day - 21 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Study Officials

  • Cynthia M Barber, PhD

    Perrigo Nutritionals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 8, 2009

First Posted

July 10, 2009

Study Start

July 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

July 10, 2009

Record last verified: 2009-07

Locations

US(1)