Study Stopped
Study was terminated due to lack of enrollment
The Effect of Feeding Infant Formula With Enriched Protein Fractions in the US
1 other identifier
interventional
2
1 country
1
Brief Summary
This study is intended to measure declarative or stored memory and behavior between infants who consume one of two infant formulas through approximately one year of age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2015
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
April 27, 2015
CompletedFirst Posted
Study publicly available on registry
May 5, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedMarch 16, 2016
March 1, 2016
2 months
April 27, 2015
March 14, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Sequence Recall using 3-dimensional props
365 days of age
Secondary Outcomes (10)
Electroencephalogram response to stimuli
180 days of age
Sequence Recall using 3-dimensional props
300 days of age
Infant Behavior Questionnaire Revised, Short
240 days of age
MacArthur-Bates Communication Development Inventory
365 days of age
Bayley Scales of Infant and Toddler Development, Third Edition
365 days of age
- +5 more secondary outcomes
Study Arms (2)
Cow's milk-based infant formula
ACTIVE COMPARATORCow milk-based infant formula with enriched protein fractions
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Singleton, 0-90 days of age at randomization
- Term infant with birth weight of a minimum of 2500 grams
- Receiving at least 75% of the recommended caloric intake from cow's milk-based infant formula
- Parent or legally authorized representative attending study visits reads, understands, and speaks English
- Signed Informed Consent and Protected Health Information authorization
You may not qualify if:
- History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised
- Feeding difficulties or formula intolerance
- Infant born small for gestational age
- Infant born from a mother who was diabetic at childbirth
- History of seizures or neurological disorders or infant with known head/brain disease/injury
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mead Johnson Nutritionlead
- University of North Carolina, Chapel Hillcollaborator
Study Sites (1)
University or North Carolina Nutrition Research Instutite
Kannapolis, North Carolina, 28081, United States
Related Publications (1)
Gonzalez-Garay AG, Serralde-Zuniga AE, Medina Vera I, Velasco Hidalgo L, Alonso Ocana MV. Higher versus lower protein intake in formula-fed term infants. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD013758. doi: 10.1002/14651858.CD013758.pub2.
PMID: 37929831DERIVED
Study Officials
- STUDY DIRECTOR
Carol Lynn Berseth, MD
Mead Johnson Nutrition
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2015
First Posted
May 5, 2015
Study Start
August 1, 2015
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
March 16, 2016
Record last verified: 2016-03