GrowthNCT00936637

Effects on Growth of an Extensively Hydrolyzed Formula Fed to Term

A study testing Extensively hydrolyzed infant formula in people with Growth, run by Perrigo Nutritionals at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 1 day to 21 daysHealthy volunteers can take part
Conditions the study is for: Growth
What is being tested?: Extensively hydrolyzed infant formula
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteUnited States
Study dates: Jul 2007to Dec 2008
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 day to 21 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

University of Virginia
Charlottesville, Virginia, 22908

Other trials in United States

About this study

Official title: A 16-Week Growth Study of an Extensively Hydrolyzed Infant Formula, 3 Months Treatment and 1 Month Follow-up for a Duration of 4 Months.

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

Conditions: Growth
Being tested: Extensively hydrolyzed infant formula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Extensively hydrolyzed infant formulaOther

Study groups in NCT00936637
Study group	Role	What they receive
Extensively hydrolyzed infant formula	Experimental	Not described Receives: Other: Extensively hydrolyzed infant formula

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2007Dec 2008

First posted10 Jul 2009 (estimated)
Study startJul 2007
Primary completionDec 2008
Study completionDec 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for GrowthStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Allocation: Randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Care provider
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00936637
Sponsor's protocol ID: UVA Growth Study
Status last verified: Jul 2009
First submitted: 8 Jul 2009
Last updated: 10 Jul 2009
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Growth trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 16-Week Growth Study of an Extensively Hydrolyzed Infant Formula, 3 Months Treatment and 1 Month Follow-up for a Duration of 4 Months.
ClinicalTrials.gov ID: NCT00936637
Acronym / sponsor ID: UVA Growth Study
Conditions: Growth
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Perrigo NutritionalsIndustry (pharma, biotech, devices)
Study start: Jul 2007
Primary completion: Dec 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 10 Jul 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Allocation: Randomised
Intervention model: Single group
Masking: Single blind (care provider)
Number of arms: 1

Arm	Type	Receives
Extensively hydrolyzed infant formula	Experimental	Other: Extensively hydrolyzed infant formula

Who may qualify

Ages: 1 day to 21 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (8 listed)

At birth:
At time of enrollment:

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Extensively hydrolyzed infant formula	Other	Extensively hydrolyzed infant formula

Primary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2009.

Related trials for Growth

Recruiting
Short-Term Reduced Dietary Protein in ER+/HER2- Breast Cancer Patients During Neoadjuvant Chemotherapy
Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
RecruitingPhase 3
Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
RecruitingPhase 2
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Breast Neoplasms, Breast Cancer
RecruitingPhase 1/2
A Study of VRN110755 in Patients With EGFR-Mutant Non-Small Cell Lung Cancer
EGFR-Mutant Non-Small Cell Lung Cancer
Active, not recruitingPhase 2
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy
Extensive-stage Small-cell Lung Cancer, Small-cell Lung Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Cynthia M Barber, PhD study director

Perrigo Nutritionals

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Extensively hydrolyzed infant formula in people with Growth, run by Perrigo Nutritionals at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

An extensively hydrolyzed formula is nutritionally adequate for normal growth of healthy full-term infants (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00936637.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2009.