Safety and Nutritional Adequacy of a New Infant Formula i... | NCT04013087

Studies
Safety and Nutritional Adequacy of a New Infant Formula in Healthy Term Infants

NCT04013087

Sponsor

Heilongjiang Feihe Dairy Co. Ltd.

Status

Unknown status

Last Update Posted

Apr 24, 2020Actual

Enrollment

450Estimated

Phase

Not Applicable

Conditions

Child Development

Interventions

Oral feeding of Feihe Stage 1 infant formula
Oral feeding of control Stage 1 formula
Breast feeding

Countries

China

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

Apr 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 8, 2019Actual

Primary Completion Date

Apr 19, 2020Actual

Completion Date

Dec 30, 2020Estimated

First Submitted Date

Jul 5, 2019

First Submission Date that Met QC Criteria

Jul 5, 2019

First Posted Date

Jul 9, 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

Apr 22, 2020

Last Update Posted Date

Apr 24, 2020Actual

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

This study is a multicenter, double-blind, randomized, controlled, parallel-designed, prospective study and is intended to evaluate the nutritional adequacy and tolerance of a new study formula compared with a concurrent control formula. Approximately 450 infants will be enrolled from approximately 3 China sites. Of these infants, approximately 300 will be randomized 1:1 to receive an investigational formula or a control formula for 16weeks of feeding. The remaining approximately 150 infants will be enrolled as a breastfeeding reference group. The primary outcome measure is the rate of weight gain in g/day between baseline and 16 weeks in the test group compared to control formula group. Participants will have the option of providing stool samples at 8 weeks and 16 weeks for analysis of microbiota and metabolomics. The study period will be 16 weeks, and all infants in the 2 formula groups will receive formula free of charge for 6 months.

Detailed Description

Primary Objective

1) Compare the rate of weight gain (in g/day) between infants receiving an investigational formula and infants receiving a control formula between at baseline (B), B+2 weeks, B+4 weeks, B+8 weeks, B+12 weeks, and B+16 weeks.

Secondary Objectives

Compare rate of change in length (mm/day) among infants receiving an investigational formula, infants receiving a control formula, and breastfeeding infants at baseline (B), B+2 weeks, B+4 weeks, B+8 weeks, B+12 weeks, and B+16 weeks.
Compare rate of change in head circumference (mm/day) among infants receiving an investigational formula, infants receiving a control formula and breastfeeding infants at baseline (B), B+2 weeks, B+4 weeks, B+8 weeks, B+12 weeks, and B+16 weeks.
Evaluate and compare achieved body weight, length, and head circumference at each visit and after 16 weeks.
Evaluate plotted raw growth data on World Health Organization standard growth charts.1
Compare the types and incidence of adverse events among infants receiving an investigational formula, infants receiving a control formula, and breastfeeding infants.
Compare average daily intake of formula between infants receiving an investigational formula and infants receiving a control formula.
Compare parents' and physician's assessment of formula tolerance among infants receiving an investigational formula, infants receiving a control formula, and breastfeeding infants.
Compare counts of Bifidobacteria and Lactobacillus species in stools of infants receiving an investigational formula, infants receiving a control formula, and breastfeeding infants.
Compare stool short-chain fatty acid metabolites (including total SCFAs, acetic, propionic, n-butyric, iso-butyric and n-valeric acids, L-lactic acid and D-lactic acid, etc) among infants receiving an investigational formula, infants receiving a control formula, and breastfeeding infants.

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

450Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test Formula	Experimental	Feihe Stage 1 infant formula	Dietary Supplement: Oral feeding of Feihe Stage 1 infant formula
Control formula	Active Comparator	A commercially available product with comparable composition but does not contain sn-2 palmitate enriched vegetable oil as an ingredient (regular vegetable oil is used)	Dietary Supplement: Oral feeding of control Stage 1 formula
Breast feeding	Other	Breast fed of human milk	Dietary Supplement: Breast feeding

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oral feeding of Feihe Stage 1 infant formula	Dietary Supplement	Oral feeding of Feihe Stage 1 infant formula for 16 weeks	Test Formula

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of change in body weight (grams/day) from baseline	Rate of change in body weight (grams/day) between baseline and B+2 weeks, B+4 weeks, B+8 weeks, B+12 weeks, and B+16 weeks.	2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks

Secondary Outcomes

Measure	Description	Time Frame
Rate of change in body length (mm/day) from baseline	Rate of change in length (mm/day) measured between baseline (B) and B+2 weeks, B+4 weeks, B+8 weeks, B+12 weeks, and B+16 weeks.	2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Rate of change in head circumference (mm/day) from baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

10-14 days of age at enrolment and randomization, inclusive (day of birth is considered day 0)
Plan to exclusively formula feed (formula groups) OR exclusively feed human milk (breastfeeding group)
Healthy singleton birth
Gestational age of 37-42 completed weeks (37 weeks 0 days through 42 weeks 6 days)
Birth weight of 2490g to 4200g
Signed informed consent obtained for infant's and mother's participation in the study

Exclusion Criteria:

History of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the Investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infant
Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake, at time of randomization (at investigator discretion)
Known allergy to cow's milk protein or a well-documented family history of allergy to cow's milk protein
Weight at randomization is <90% of birth weight [(weight at Visit 1÷birth weight) x 100 <90%]
Immunocompromised (according to a doctor's diagnosis of immunodeficiency such as Combined Immunodeficiencies, DiGeorge Syndrome, Wiskott-Aldrich Syndrome, Severe Congenital Neutropenia and Secondary Immunodeficiencies linked to HIV infection, Down Syndrome or others)
Known head/brain disease/injury such as microcephaly, macrocephaly or others.
Enrollment in another interventional clinical research study while participating in this study

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Days

Maximum Age

14 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fei Li, PhD	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jinhua Nanyuan Community Health Center (site 1919)		Jinhua	Zhejiang		China
Jinhua Qiubin Community Health Center (site 1969)

ID	Term
D055703	Reproductive Physiological Phenomena
D012101	Reproductive and Urinary Physiological Phenomena
D049590	Postpartum Period