Growth Clinical Trial
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.
Verified date | July 2009 |
Source | Perrigo Nutritionals |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The purpose of this study is to assess growth in infants who are fed an extensively hydrolyzed formula.
Status | Completed |
Enrollment | 35 |
Est. completion date | December 2008 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A to 21 Days |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver)
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia | Charlottesville | Virginia |
Lead Sponsor | Collaborator |
---|---|
Perrigo Nutritionals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | An extensively hydrolyzed formula is nutritionally adequate for normal growth of healthy full-term infants | 16 weeks | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05551975 -
Preterm Infants Fed a Human Milk Fortifier
|
N/A | |
Completed |
NCT01721512 -
The Growth and Development of Breast and Formula Fed Term Asian Infants
|
N/A | |
Completed |
NCT01162798 -
Preterm Infant Growth
|
N/A | |
Active, not recruiting |
NCT00970398 -
Effect of an Infant Formula on Infant Growth, Health and Immune Functions
|
N/A | |
Completed |
NCT01666457 -
Impact of Implementing an Infant Driven Feeding Program on Oral Feeding and Growth Outcomes of Medically Fragile Infants in the Neonatal ICU (NICU)
|
||
Completed |
NCT00808756 -
Study on Fermentable Carbohydrates in Healthy Infants
|
N/A | |
Completed |
NCT00997971 -
Growth, Tolerance in Healthy Infants Fed a Partially Hydrolyzed Rice Protein
|
Phase 3 | |
Completed |
NCT03276663 -
Growth of Healthy Term Infants Fed a Partially Hydrolyzed Follow-up Formula
|
N/A | |
Recruiting |
NCT02695784 -
Probiotics After Discharge
|
Phase 4 | |
Withdrawn |
NCT02860026 -
Growth and Tolerance of Healthy Term Infants Fed Cow's Milk-Based Infant Formulas
|
N/A | |
Completed |
NCT01128517 -
Maternal Education on Complementary Feeding and Infant Outcome
|
N/A | |
Completed |
NCT00282113 -
Effects of Probiotic and Prebiotic Combinations on Premature Infants
|
N/A | |
Completed |
NCT03276884 -
Growth and Tolerance of Young Infants
|
N/A | |
Completed |
NCT04055363 -
Human Milk Oligosaccharides (HMOs) Post-market Study on Infants
|
N/A | |
Completed |
NCT05302427 -
Infant Massage and Infant Growth, Mother-Infant Attachment, and Maternal Self-Confidence
|
N/A | |
Not yet recruiting |
NCT05616117 -
Next-generation Effects of Vitamin D Supplementation in Pregnancy
|
||
Active, not recruiting |
NCT02410057 -
Growth and Metabolism in Infants Fed Protein-reduced, Alpha-lactalbumin Enriched Formula
|
N/A | |
Completed |
NCT01158352 -
Study to Evaluate the Effect of Short Treatment With Nutritional Supplementation Standardized Innovative Formula, on Growth and Weight Gain in Short and Lean Prepubertal Children
|
N/A | |
Completed |
NCT01210391 -
Growth of Infants Fed an Extensively Hydrolyzed Infant Formula
|
N/A | |
Completed |
NCT01109849 -
Novel Approach to Stimulant Induced Weight Suppression and Its Impact on Growth
|
Phase 4 |