Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02860026
Other study ID # 3388-1
Secondary ID
Status Withdrawn
Phase N/A
First received August 3, 2016
Last updated May 26, 2017
Start date October 2016
Est. completion date April 2018

Study information

Verified date May 2017
Source Mead Johnson Nutrition
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This clinical trial will compare the growth and tolerance of infants who consume an investigational cow's milk-based infant formula to those who consume a marketed cow's milk-based infant formula through approximately 4 months of age.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date April 2018
Est. primary completion date March 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 14 Days
Eligibility Inclusion Criteria:

- Singleton 10-14 days of age at randomization

- Term infant with birth weight of minimum of 2500 grams

- Solely formula fed

- Signed informed consent and protected health information

Exclusion Criteria:

- History of underlying metabolic or chronic disease, anemia, or immune compromise

- Feeding difficulties or formula intolerance

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Marketed cow's milk-based infant formula

Cow's milk-based infant formula with added nutrients


Locations

Country Name City State
United States Kentucky Pediatrics/Adult Research Bardstown Kentucky
United States Birmingham Pediatric Associates Birmingham Alabama
United States Coastal Pediatric Research Charleston South Carolina
United States Pediatric Associates of Mt. Carmel, Inc. Cincinnati Ohio
United States Ohio Pediatric Research Association Dayton Ohio
United States Southeastern Pediatric Associates Dothan Alabama
United States Deaconess Clinical Research Evansville Indiana
United States Pediatric Associates of Fairfield, Inc. Fairfield Ohio
United States Northwest Arkansas Pediatric Clinic Fayetteville Arkansas
United States The Jackson Clinic - North Jackson Jackson Tennessee
United States The Children's Clinic of Jonesboro, P.A. Jonesboro Arkansas
United States Holston Medical Group Kingsport Tennessee
United States Altamonte Pediatric Associates Lake Mary Florida
United States DCOL Center for Clinical Research Longview Texas
United States Norwich Pediatric Group, P.C. Norwich Connecticut
United States Owensboro Pediatrics Owensboro Kentucky
United States UHMP Comprehensive Pediatrics Westlake Ohio

Sponsors (1)

Lead Sponsor Collaborator
Mead Johnson Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of body weight gain from 14 to 120 days of age 3.5 months
Secondary Recall of infant formula at each study visit Up to 3.5 months
Secondary Body length measured at each study visit Up to 3.5 months
Secondary Recall of stool characteristics questionnaire measured at each study visit Up to 3.5 months
Secondary Head circumference measured at each study visit Up to 3.5 months
Secondary Recall of gastrointestinal tolerance questionnaire at each study visit Up to 3.5 months
Secondary Medically confirmed adverse events collected throughout the study period Up to 3.5 months
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05551975 - Preterm Infants Fed a Human Milk Fortifier N/A
Completed NCT01162798 - Preterm Infant Growth N/A
Completed NCT01721512 - The Growth and Development of Breast and Formula Fed Term Asian Infants 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
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 NCT01210391 - Growth of Infants Fed an Extensively Hydrolyzed Infant 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 NCT01109849 - Novel Approach to Stimulant Induced Weight Suppression and Its Impact on Growth Phase 4
Completed NCT00705445 - Evaluation of Zinc and / or Micronutrient Supplementation on Intestinal Flora, Diarrheal Disease Burden, Intestinal Mucosal Integrity and Growth Among Children of Pakistan Phase 2/Phase 3