Feeding Tolerance Evaluation | NCT02405572

Studies
Feeding Tolerance Evaluation

NCT02405572

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

May 12, 2016Estimated

Enrollment

43Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

infant formula

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Mar 2016Actual

Completion Date

Not provided

First Submitted Date

Feb 23, 2015

First Submission Date that Met QC Criteria

Mar 27, 2015

First Posted Date

Apr 1, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2016

Last Update Posted Date

May 12, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Crossover study of 2 infant formulas

Detailed Description

Exclusively formula-fed infants will participate in two 2-week feeding periods of 2 infant formulas. Daily tolerance records will be kept by caregivers.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

43Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Formula 1	Active Comparator	infant formula	Other: infant formula
Formula 2	Active Comparator	infant formula	Other: infant formula

Interventions

Name	Type	Description	Arm Group Labels	Other Names
infant formula	Other	infant formulas	Formula 1 Formula 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
stool consistency	caregivers will document on diary records	2 weeks

Secondary Outcomes

Measure	Description	Time Frame
spit-up pattern	caregivers will document on diary records	2 weeks
formula intake	caregivers will document on diary records	2 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy newborn infant
Full-term (> 37 weeks gestation)
0-2 months (birth-56 days) of age on enrollment
Infant exclusively formula-fed for at least 2 days prior to enrollment
Having obtained his/her legal representative's informed consent

Exclusion Criteria:

Known or suspected cow-milk allergy
Congenital illness or malformation
Significant prenatal and/or postnatal disease
Currently participating in another clinical study

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

2 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rich Litov, PhD	Pedia Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pedia Research		Owensboro	Kentucky	47630	United States
Tanner Clinic

Intervention Browse Module

MeSH Terms

ID	Term
D041943	Infant Formula

Ancestor Terms

ID	Term
D041941	Milk Substitutes
D001628	Beverages
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided