Evaluation of Infants Fed an Extensively Hydrolyzed Infan... | NCT03884309

Studies
Evaluation of Infants Fed an Extensively Hydrolyzed Infant Formula

NCT03884309

Sponsor

Abbott Nutrition

Status

Completed

Last Update Posted

Feb 5, 2020Actual

Enrollment

48Actual

Phase

Not Applicable

Conditions

Protein Intolerance

Interventions

Experimental Hydrolyzed Protein 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

Jan 2020

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

Mar 25, 2019Actual

Primary Completion Date

Jan 7, 2020Actual

Completion Date

Jan 7, 2020Actual

First Submitted Date

Mar 18, 2019

First Submission Date that Met QC Criteria

Mar 19, 2019

First Posted Date

Mar 21, 2019Actual

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

Jan 31, 2020

Last Update Posted Date

Feb 5, 2020Actual

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

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental Hydrolyzed Protein Infant Formula	Experimental	hydrolyzed protein infant formula powder in cans	Other: Experimental Hydrolyzed Protein Infant Formula

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Experimental Hydrolyzed Protein Infant Formula	Other	fed ad libitum	Experimental Hydrolyzed Protein Infant Formula

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weight for Age	Change in weight for age z-score	Study Day 1 to Study Day 60

Secondary Outcomes

Measure	Description	Time Frame
Gastrointestinal Tolerance	Parent completed diary questions	Study Day 1 to Study Day 60
Length	Gain measured in cm	Study Day 1 to Study Day 60

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant is presently consuming an extensively hydrolyzed infant formula (EHF) for persistent feeding intolerance symptoms, symptoms of suspected food protein (milk and/or soy) sensitivity, or other conditions where EHF is deemed an appropriate feeding.
Parent(s) of infants confirm their intention not to administer prescription medications, over the counter medications, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect GI tolerance.
Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study.
Parent(s) confirm their intention not to administer vitamins, minerals (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study.
Participant's parent(s) or a legally authorized representative (LAR) has voluntarily signed and dated an informed consent form (ICF) approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.

Exclusion Criteria:

An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on growth, and/or development.
Participant is receiving oral or inhaled steroids.
Participant participates in another study that has not been approved as a concomitant study.
Participant has an allergy or intolerance to any ingredient in the study product.
Participant has been treated with antibiotics or other medications that in the opinion of the PI may affect growth, GI tolerance and/or development, within 2 weeks prior to enrollment.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

60 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Paramount Research Solutions		College Park	Georgia	30349	United States
Michael W. Simon, M.D., PSC