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出境医 / 临床实验 / Safety and Nutritional Adequacy of a New Infant Formula in Healthy Term Infants
Safety and Nutritional Adequacy of a New Infant Formula in Healthy Term Infants
Study Description
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Child Development | Dietary Supplement: Oral feeding of Feihe Stage 1 infant formula Dietary Supplement: Oral feeding of control Stage 1 formula Dietary Supplement: Breast feeding | Not Applicable |
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.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 450 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Basic Science |
| Official Title: | Randomized, Double-blind, Parallel, Controlled Study to Evaluate the Safety and Nutritional Adequacy of a New Infant Formula in Healthy Term Infants |
| Actual Study Start Date : | July 8, 2019 |
| Actual Primary Completion Date : | April 19, 2020 |
| Estimated Study Completion Date : | December 30, 2020 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Test Formula
Feihe Stage 1 infant formula
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Dietary Supplement: Oral feeding of Feihe Stage 1 infant formula
Oral feeding of Feihe Stage 1 infant formula for 16 weeks
|
|
Active Comparator: Control formula
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
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 feeding
Breast fed of human milk
|
Dietary Supplement: Breast feeding
Breast feeding of human milk for 16 weeks
|
Outcome Measures
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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 length (mm/day) measured between baseline (B) and B+2 weeks, B+4 weeks, B+8 weeks, B+12 weeks, and B+16 weeks.
- Rate of change in head circumference (mm/day) from baseline [ Time Frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks ]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.
- Achieved body weight [ Time Frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks ]Achieved body weight (grams) at each study visit
- Achieved body length [ Time Frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks ]Achieved body length (cm) at each study visit
- Achieved head circumference [ Time Frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks ]Achieved head circumference (cm) at each study visit
- 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 weight for age.
- 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 length for age.
- Percentages of infants in each group who are <10th percentile in head circumference for age. [ Time Frame: 16 weeks ]Percentages of infants in each group who are <10th percentile in head circumference for age.
- Adverse events rate [ Time Frame: 16 weeks ]Number and percentages of infants in each group experiencing any adverse events and any serious adverse events
- Average daily formula intake [ Time Frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks ]Average daily formula intake volume based on 3-day records kept by parents or care-givers prior to each study visit.
- Percentage of fussiness [ Time Frame: 16 weeks ]Percentages of parents in each group reporting fussiness
- Percentage of colic [ Time Frame: 16 weeks ]Percentages of parents in each group reporting colic
- Percentage of patterns [ Time Frame: 16 weeks ]Percentages of parents in each group reporting sleeping patterns
- Percentage of cramps [ Time Frame: 16 weeks ]Percentages of parents in each group reporting cramps
- Percentage of regurgitation [ Time Frame: 16 weeks ]Percentages of parents in each group reporting regurgitation
- Stool characteristics [ Time Frame: 16 weeks ]Score of stool characteristics
- Percentage of respiratory manifestations [ Time Frame: 16 weeks ]Percentages of parents in each group reporting respiratory manifestations
- Percentage of dermatologic manifestations [ Time Frame: 16 weeks ]Percentages of parents in each group reporting dermatologic manifestations
- Fecal Bifidobacteria counts [ Time Frame: 8 weeks,16 weeks ]Total fecal Bifidobacteria counts (mean log10 counts / g wet-weight stool) at 8 weeks and 16 weeks.
- Fecal Lactobacillus counts [ Time Frame: 8 weeks,16 weeks ]Total fecal Lactobacillus counts (mean log10 counts / g wet-weight stool) at 8 weeks and 16 weeks.
- Stool short-chain fatty acid [ Time Frame: 8 weeks,16 weeks ]Total stool short-chain fatty acid metabolites in mg/g dry stool at 8 weeks and 16 weeks.
Eligibility Criteria
| Ages Eligible for Study: | up to 14 Days (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Locations
| China, Zhejiang | |
| Jinhua Nanyuan Community Health Center (site 1919) | |
| Jinhua, Zhejiang, China | |
| Jinhua Qiubin Community Health Center (site 1969) | |
| Jinhua, Zhejiang, China | |
| Jinhua Xiguan Community Health Center (site 1966) | |
| Jinhua, Zhejiang, China | |
Sponsors and Collaborators
Heilongjiang Feihe Dairy Co. Ltd.
Investigators
| Principal Investigator: | Fei Li, PhD | Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 5, 2019 | ||||
| First Posted Date ICMJE | July 9, 2019 | ||||
| Last Update Posted Date | April 24, 2020 | ||||
| Actual Study Start Date ICMJE | July 8, 2019 | ||||
| Actual Primary Completion Date | April 19, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Safety and Nutritional Adequacy of a New Infant Formula in Healthy Term Infants | ||||
| Official Title ICMJE | Randomized, Double-blind, Parallel, Controlled Study to Evaluate the Safety and Nutritional Adequacy of a New Infant Formula in Healthy Term Infants | ||||
| 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
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
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| Condition ICMJE | Child Development | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE |
450 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | December 30, 2020 | ||||
| Actual Primary Completion Date | April 19, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | up to 14 Days (Child) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04013087 | ||||
| Other Study ID Numbers ICMJE | 18-SM-12-FEIHE-001 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Heilongjiang Feihe Dairy Co. Ltd. | ||||
| Study Sponsor ICMJE | Heilongjiang Feihe Dairy Co. Ltd. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Heilongjiang Feihe Dairy Co. Ltd. | ||||
| Verification Date | April 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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