CompletedNCT00936637Updated Jul 10, 2009

Effects on Growth of an Extensively Hydrolyzed Formula Fed to Term

An interventional study of Extensively hydrolyzed infant formula in Growth, sponsored by Perrigo Nutritionals. Completed at 1 site in United States. Open to participants aged 1 Day to 21 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-07-10.

Sponsored by Perrigo Nutritionals · Not applicable and Interventional

Phase: Not applicable
Study type: Interventional
Enrollment: 35
Allocation: Randomized
Ages: 1 Day to 21 Days
Sex: All

Study summary

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

Conditions studied

Growth

In context

Lead sponsor

Perrigo Nutritionals is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 1 Day to 21 Days
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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

Study design

Phase: Not applicable
Allocation: Randomized
Intervention model: Single group
Masking: Single (Care provider)
Enrollment: 35 participants (actual)

Study arms

Experimental
Extensively hydrolyzed infant formula
Other: Extensively hydrolyzed infant formula

Interventions

OtherExtensively hydrolyzed infant formula

What researchers measure

Primary outcomes

An extensively hydrolyzed formula is nutritionally adequate for normal growth of healthy full-term infants
Time frame: 16 weeks

Study locations

1 site

University of Virginia
Charlottesville, Virginia 22908, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 10, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00936637
Lead sponsor: Perrigo Nutritionals
First posted: Jul 10, 2009
Start date: Jul 2007
Primary completion: Dec 2008
Completion: Dec 2008
Last update: Jul 10, 2009

Study contacts

Cynthia M Barber, PhD

study director · Perrigo Nutritionals

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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