Growth and Tolerance Trial on Infant Formula With HMO | NCT04066413

Studies
Growth and Tolerance Trial on Infant Formula With HMO

NCT04066413

Sponsor

FrieslandCampina

Status

Terminated

Last Update Posted

Sep 28, 2023Actual

Enrollment

265Actual

Phase

Not Applicable

Conditions

Healthy Growth

Interventions

Standard infant formula
Infant formula supplemented with HMO

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

Sep 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to recruitment difficulties

Expanded Access Info

Start Date

Sep 23, 2019Actual

Primary Completion Date

Jan 26, 2023Actual

Completion Date

Jan 26, 2023Actual

First Submitted Date

Aug 21, 2019

First Submission Date that Met QC Criteria

Aug 22, 2019

First Posted Date

Aug 26, 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

Sep 26, 2023

Last Update Posted Date

Sep 28, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

The aim of the study is to compare growth of healthy infants fed an infant formula supplemented with a human milk oligosaccharide to that of infants on standard formula.

Detailed Description

Not provided

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

265Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Breastfed group	No Intervention	Non-randomized breastfed reference group
Control formula	Placebo Comparator	Group receiving standard infant formula	Other: Standard infant formula
Formula with HMO	Active Comparator	Group receiving standard infant formula supplemented with HMO	Other: Infant formula supplemented with HMO

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standard infant formula	Other	Standard infant formula	Control formula

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Growth	Infant growth measured as body weight gain per day	From enrollment until end of the 3 month-study

Secondary Outcomes

Measure	Description	Time Frame
Weight	Infant weight (kg)	Monthly, from enrollment until end of the 3 month-study
Recumbent length	Infant length (cm and cm/day)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Gestational age ≥ 37 weeks
Birth weight ≥ 2500 grams
No recognized diseases (such as cardiac, pulmonary, gastrointestinal, renal or genetic diseases)
Boys and girls
Recruited < 1 month/age
Being available for follow up until the age of 4 months
Exclusive formula feeding or exclusive breast feeding at time of recruitment

Exclusion Criteria:

Gestational age <37 weeks
Birth weight <2500 grams
Severe acquired or congenital diseases, mental or physical disorders
Illness at screening/ inclusion
Incapability of parents/caregivers to comply with the study protocol
Received antibiotics within the first month of life
Not tolerating standard cow's milk based infant formula
Participation in another clinical trial
Maternal illicit drug use during pregnancy or post-partum period
Parent/caregiver does not have a cell phone to use for filling out questionnaires

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

1 Month

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cincinnati Children's Hospital Medical Center		Cincinnati	Ohio	45229-3026	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006279	Health Maintenance Organizations

Ancestor Terms

ID	Term
D008329	Managed Care Programs
D007348	Insurance, Health
D007341	Insurance
D005381	Financing, Organized

Browse Leaves

Not provided

Browse Branches

Not provided