Clinical trial NCT02274883: The Effect of Feeding Infant Formula With Enriched Protein Fractions
Official title: The Effect of Feeding Infant Formula With Enriched Protein Fractions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Ability, General
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Children's Medical Center
First posted: 2014-10-24
Enrollment: 451
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is intended to evaluate the nutritive effects of study formulas on growth and cognitive outcomes.

Detailed description: To evaluate the nutritive effects of study formulas on growth and cognitive outcomes.

Eligibility criteria: Inclusion Criteria:

* 10-14 days of age
* Exclusively formula-fed
* Singleton birth
* Gestational age of 37-42 weeks
* Birth weight of 2500g to 4000g
* Signed Informed Consent Form

Exclusion Criteria:

* History of underlying metabolic or chronic disease
* Congenital malformation
* Condition which is likely to interfere with food ingestion, normal growth, development and evaluation
* Evidence of feeding difficulties or intolerance
* Immunocompromised
* Head/brain disease/injury

Primary outcomes:
measure: Infant cognitive development
timeFrame: At 12 months of age
Secondary outcomes:
measure: Infant cognitive development
timeFrame: At 18 months of age
measure: Infant language and motor skills
timeFrame: At 4, 6, 9, 12 and 18 months of age
measure: Infant acquisition of social and emotional milestones and adaptive development
timeFrame: At 4, 6, 9, 12 and 18 months of age
measure: Infant temperament
timeFrame: At 12 and 18 months of age
measure: Infant attention capabilities
timeFrame: At 12 and 18 months of age
measure: Physical development
timeFrame: At 14, 30, 42, 60, 90, 120, 180, 275, 365, and 545 days of age
measure: Stool characteristics
timeFrame: At 14, 30, 42, 60, 90, 120, 180, 275 and 365 days of age
measure: Formula intake
timeFrame: At 30, 42, 60, 90, 120, 180, 275 and 365 days of age
measure: Fecal microbiome and metabolome profile
timeFrame: Average of 14 days of age and 120 days of age
measure: Medically-confirmed Adverse Events
timeFrame: Up to 19 months of age
Other outcomes:
Locations:
city: Fuyang
country: China
facility: Fuyang Fifth People's Hospital
state: Anhui
city: Fuyang
country: China
facility: Fuyang Maternal and Child Health Institute
state: Anhui
city: Fuyang
country: China
facility: Yinquan Maternal and Child Health Institute
state: Anhui
Study officials:
affiliation: University of Kansas
name: John Colombo, Doctor
role: STUDY_CHAIR
affiliation: Shanghai Children's Medical Center
name: Fei Li, Doctor
role: STUDY_CHAIR
affiliation: Mead Johnson Nutrition
name: Bryan Liu, Doctor
role: STUDY_DIRECTOR
References:
citation: Chichlowski M, Bokulich N, Harris CL, Wampler JL, Li F, Berseth CL, Rudolph C, Wu SS. Effect of Bovine Milk Fat Globule Membrane and Lactoferrin in Infant Formula on Gut Microbiome and Metabolome at 4 Months of Age. Curr Dev Nutr. 2021 Apr 2;5(5):nzab027. doi: 10.1093/cdn/nzab027. eCollection 2021 May.
citation: Li F, Wu SS, Berseth CL, Harris CL, Richards JD, Wampler JL, Zhuang W, Cleghorn G, Rudolph CD, Liu B, Shaddy DJ, Colombo J. Improved Neurodevelopmental Outcomes Associated with Bovine Milk Fat Globule Membrane and Lactoferrin in Infant Formula: A Randomized, Controlled Trial. J Pediatr. 2019 Dec;215:24-31.e8. doi: 10.1016/j.jpeds.2019.08.030. Epub 2019 Oct 24.