NCT02274883

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
451

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

October 16, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 24, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

September 1, 2017

Status Verified

August 1, 2017

Enrollment Period

1.9 years

First QC Date

October 16, 2014

Last Update Submit

August 31, 2017

Conditions

Cognitive Ability, General

Outcome Measures

Primary Outcomes (1)

  • Infant cognitive development

    Cognitive Scale of Bayley-III is used as the assessment tool.

    At 12 months of age

Secondary Outcomes (10)

  • Infant cognitive development

    At 18 months of age

  • Infant language and motor skills

    At 4, 6, 9, 12 and 18 months of age

  • Infant acquisition of social and emotional milestones and adaptive development

    At 4, 6, 9, 12 and 18 months of age

  • Infant temperament

    At 12 and 18 months of age

  • Infant attention capabilities

    At 12 and 18 months of age

  • +5 more secondary outcomes

Study Arms (2)

Enriched Protein Fractions

EXPERIMENTAL

This group is given Infant formula with enriched protein fractions.

Dietary Supplement: Enriched Protein Fractions

Protein Fractions

ACTIVE COMPARATOR

This group is given Infant formula with protein fractions.

Dietary Supplement: Protein Fractions

Interventions

Enriched Protein FractionsDIETARY_SUPPLEMENT

Enriched protein fractions

Enriched Protein Fractions
Protein FractionsDIETARY_SUPPLEMENT

Protein fractions

Protein Fractions

Eligibility Criteria

Age10 Days - 14 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Fuyang Fifth People's Hospital

Fuyang, Anhui, China

Location

Fuyang Maternal and Child Health Institute

Fuyang, Anhui, China

Location

Yinquan Maternal and Child Health Institute

Fuyang, Anhui, China

Location

Related Publications (2)

  • 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.

    PMID: 33981943DERIVED

  • 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.

    PMID: 31668885DERIVED

Study Officials

  • John Colombo, Doctor

    University of Kansas

    STUDY CHAIR

  • Fei Li, Doctor

    Shanghai Children's Medical Center

    STUDY CHAIR

  • Bryan Liu, Doctor

    Mead Johnson Nutrition

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2014

First Posted

October 24, 2014

Study Start

November 1, 2014

Primary Completion

October 1, 2016

Study Completion

May 1, 2017

Last Updated

September 1, 2017

Record last verified: 2017-08

Locations

CN(3)