Child DevelopmentNCT04013087
Safety and Nutritional Adequacy of a New Infant Formula in Healthy Term Infants
A study testing Oral feeding of Feihe Stage 1 infant formula and Breast feeding in people with Child Development, run by Heilongjiang Feihe Dairy Co. Ltd. at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Child Development
- What is being tested?
- Oral feeding of Feihe Stage 1 infant formula and Breast feeding
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 3 sitesChina
- Study dates
- 8 Jul 2019to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
China3 sites
Jinhua Nanyuan Community Health Center (site 1919)
Jinhua, Zhejiang
Jinhua Qiubin Community Health Center (site 1969)
Jinhua, Zhejiang
Jinhua Xiguan Community Health Center (site 1966)
Jinhua, Zhejiang
About this study
Official title: Randomized, Double-blind, Parallel, Controlled Study to Evaluate the Safety and Nutritional Adequacy of a New Infant Formula in Healthy Term Infants
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.
Read the detailed description
Primary Objective
- 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.
- Conditions
- Child Development
- Being tested
- Oral feeding of Feihe Stage 1 infant formula, Oral feeding of control Stage 1 formula, Breast feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral feeding of Feihe Stage 1 infant formulaDietary supplement
Oral feeding of Feihe Stage 1 infant formula for 16 weeks
Oral feeding of control Stage 1 formulaDietary supplement
Oral feeding of control Stage 1 formula for 16 weeks (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))
Breast feedingDietary supplement
Breast feeding of human milk for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Test Formula | Experimental | Feihe Stage 1 infant formula Receives: 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) Receives: Dietary Supplement: Oral feeding of control Stage 1 formula |
| Breast feeding | Other | Breast fed of human milk Receives: Dietary Supplement: Breast feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Secondary outcomes (21)
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.
Measured: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Rate of change in head circumference (mm/day) from baseline
Rate of change in head circumference (mm/day) measured between baseline (B) and B+2 weeks, B+4 weeks, B+8 weeks, B+12 weeks, and B+16 weeks.
Measured: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Achieved body weight
Achieved body weight (grams) at each study visit
Measured: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Achieved body length
Achieved body length (cm) at each study visit
Measured: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Achieved head circumference
Achieved head circumference (cm) at each study visit
Measured: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Percentages of infants in each group who are <10th percentile in weight for age.
Percentages of infants in each group who are <10th percentile in weight for age.
Measured: 16 weeks
Percentages of infants in each group who are <10th percentile in length for age.
Percentages of infants in each group who are <10th percentile in length for age.
Measured: 16 weeks
Percentages of infants in each group who are <10th percentile in head circumference for age.
Percentages of infants in each group who are <10th percentile in head circumference for age.
Measured: 16 weeks
Adverse events rate
Number and percentages of infants in each group experiencing any adverse events and any serious adverse events
Measured: 16 weeks
Average daily formula intake
Average daily formula intake volume based on 3-day records kept by parents or care-givers prior to each study visit.
Measured: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Percentage of fussiness
Percentages of parents in each group reporting fussiness
Measured: 16 weeks
Percentage of colic
Percentages of parents in each group reporting colic
Measured: 16 weeks
Percentage of patterns
Percentages of parents in each group reporting sleeping patterns
Measured: 16 weeks
Percentage of cramps
Percentages of parents in each group reporting cramps
Measured: 16 weeks
Percentage of regurgitation
Percentages of parents in each group reporting regurgitation
Measured: 16 weeks
Stool characteristics
Score of stool characteristics
Measured: 16 weeks
Percentage of respiratory manifestations
Percentages of parents in each group reporting respiratory manifestations
Measured: 16 weeks
Percentage of dermatologic manifestations
Percentages of parents in each group reporting dermatologic manifestations
Measured: 16 weeks
Fecal Bifidobacteria counts
Total fecal Bifidobacteria counts (mean log10 counts / g wet-weight stool) at 8 weeks and 16 weeks.
Measured: 8 weeks,16 weeks
Fecal Lactobacillus counts
Total fecal Lactobacillus counts (mean log10 counts / g wet-weight stool) at 8 weeks and 16 weeks.
Measured: 8 weeks,16 weeks
Stool short-chain fatty acid
Total stool short-chain fatty acid metabolites in mg/g dry stool at 8 weeks and 16 weeks.
Measured: 8 weeks,16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start8 Jul 2019
- Primary completion19 Apr 2020
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heilongjiang Feihe Dairy Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fei Li, PhD, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013087
- Sponsor's protocol ID
- 18-SM-12-FEIHE-001
- Status last verified
- Apr 2020
- First submitted
- 5 Jul 2019
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Parallel, Controlled Study to Evaluate the Safety and Nutritional Adequacy of a New Infant Formula in Healthy Term Infants
- ClinicalTrials.gov ID
- NCT04013087
- Acronym / sponsor ID
- 18-SM-12-FEIHE-001
- Conditions
- Child Development
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Heilongjiang Feihe Dairy Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- 19 Apr 2020 (actual)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 9 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test Formula | Experimental | Dietary Supplement: Oral feeding of Feihe Stage 1 infant formulaFeihe Stage 1 infant formula |
| Control formula | Active comparator | Dietary Supplement: Oral feeding of control Stage 1 formulaA commercially available product with comparable composition but does not contain sn-2 palmitate enriched vegetable oil as an ingredient (regular vegetable oil is used) |
| Breast feeding | Other | Dietary Supplement: Breast feedingBreast fed of human milk |
Who may qualify
- Ages
- 10 to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral feeding of Feihe Stage 1 infant formulaOral feeding of Feihe Stage 1 infant formula for 16 weeks | Dietary supplement | Test Formula |
| Oral feeding of control Stage 1 formulaOral feeding of control Stage 1 formula for 16 weeks (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 | Control formula |
| Breast feedingBreast feeding of human milk for 16 weeks | Dietary supplement | Breast feeding |
Primary outcome
Rate of change in body weight (grams/day) from baseline
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
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.
21 secondary outcomes
Rate of change in body length (mm/day) from baseline
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Rate of change in head circumference (mm/day) from baseline
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Achieved body weight
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Achieved body length
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Achieved head circumference
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Percentages of infants in each group who are <10th percentile in weight for age.
Time frame: 16 weeks
Percentages of infants in each group who are <10th percentile in length for age.
Time frame: 16 weeks
Percentages of infants in each group who are <10th percentile in head circumference for age.
Time frame: 16 weeks
Adverse events rate
Time frame: 16 weeks
Average daily formula intake
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Percentage of fussiness
Time frame: 16 weeks
Percentage of colic
Time frame: 16 weeks
Percentage of patterns
Time frame: 16 weeks
Percentage of cramps
Time frame: 16 weeks
Percentage of regurgitation
Time frame: 16 weeks
Stool characteristics
Time frame: 16 weeks
Percentage of respiratory manifestations
Time frame: 16 weeks
Percentage of dermatologic manifestations
Time frame: 16 weeks
Fecal Bifidobacteria counts
Time frame: 8 weeks,16 weeks
Fecal Lactobacillus counts
Time frame: 8 weeks,16 weeks
Stool short-chain fatty acid
Time frame: 8 weeks,16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
Related trials for Child Development
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Not yet recruiting
Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
Hearing Loss, Bilateral
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fei Li, PhD principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral feeding of Feihe Stage 1 infant formula and Breast feeding in people with Child Development, run by Heilongjiang Feihe Dairy Co. Ltd. at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of change in body weight (grams/day) from baseline (time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.