Infant DevelopmentNCT03614468
New Infant Formula Supports Adequate Growth in Healthy Infants
A study testing Formula A and Formula B in people with Infant Development, run by Worthy Health.
Trial summary
The objective of the present study is to evaluate the growth, safety, and tolerance in healthy, term infants consuming a new to market infant formula (Formula A) and a commercially available infant formula (Formula B) with daily weight gain as the primary outcome. Read more about this study
- Who is it for?
- Ages 1 day to 21 daysHealthy volunteers can take part
- Conditions the study is for
- Infant Development
- What is being tested?
- Formula A and Formula B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 8 May 2019to 25 May 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 1 day to 21 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants will be eligible to participate if they meet all of the following conditions. At birth the infant must be:
- Only infants whose parent(s) or legal guardian(s) have decided to feed infant formula as the sole source of nutrition, will be approached for potential study enrollment
- Healthy, term (early term/no less than 37 weeks, 0 days through late term/no greater than 41 weeks, 6 days), singleton infant
- Have a birth weight of ≥ 2500 grams
- At the time of the baseline/enrollment visit, infants must be:
- Designated as healthy by a physician
Show all 14Show fewer
- ≤21 days post-natal age (Date of Birth = Day 0)
- Weight for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
- Length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
- Head circumference for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
- Weight for length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
- Exclusively consuming and tolerating a cow's milk infant formula at time of enrollment
- Have parent(s) or legal guardian(s) who agree to feed the study formula to the study subject as his/her sole source of nutrition for the duration of the study
- Have parent(s) or legal guardian(s) who have read and voluntarily signed an Informed Consent form approved by the Institutional Review Board prior to any participation in the study.
Who cannot join
- Infants will be ineligible if they have any of the following conditions that are judged by a physician to interfere with the infant's normal growth, development, and/or tolerance to an infant formula:
- Infants showing evidence of anatomic and physiologic defects of the respiratory tract, or other congenital defects (as determined by the clinician)
- Evidence of chronic hepatic, gastrointestinal, renal, cardiac, pulmonary, or neurological diseases
- Having a maternal history with known adverse effects on the fetus and/or the newborn infant, such as diabetes (gestational diabetes is acceptable if infant's birth weight is < 4300 g), active tuberculosis, perinatal infection,
- Having a family history of cow's milk protein intolerance/allergy
- Are an infant from a multiple birth (twin, triplet, etc.)
- Mothers who smoked cigarettes
- Mothers who used illicit drugs during pregnancy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: New Infant Formula Supports Adequate Growth and Safety Study in Healthy Infants
The objective of the present study is to evaluate the growth, safety, and tolerance in healthy, term infants consuming a new to market infant formula (Formula A) and a commercially available infant formula (Formula B) with daily weight gain as the primary outcome. As secondary outcomes, the study will evaluate other growth parameters, tolerance, and safety.
Read the detailed description
This is a controlled randomized parallel assignment, masked (Participant, Care Provider, Investigator, Outcomes Assessor) study. Healthy infants will be assigned an Investigational (Formula A) experimental new milk based infant formula, or an active comparator Control (Formula B) Enfamil (trademark brand name) marketed milk based infant formula. The period for the study is 365 days (52 weeks) using repeated-measures mixed model (RMMM). Anthropometry, formula intake, tolerance, and stool characteristics will be assessed. Medically confirmed adverse events will be recorded throughout the study.
- Conditions
- Infant Development
- Being tested
- Formula A, Formula B
- Keywords
- Infant Formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formula AOther
Formula A is to be feed as the sole source of nutrition for 52 weeks to healthy term infants.
Formula BOther
Formula B is to be feed as the sole source of nutrition for 52 weeks to healthy term infants.
| Study group | Role | What they receive |
|---|---|---|
| Formula A | Experimental | An experimental Infant Formula, Milk-Based Powder with Iron, for healthy term infants 0 to 12 months of age. Receives: Other: Formula A |
| Formula B | Active comparator | A Commercially available Infant Formula, for healthy term infants 0 to 12 months of age (Enfamil TM, Milk-Based Powder with Iron) Receives: Other: Formula B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain change measured at set intervals for first 365 days
The infants will be weighed naked while lying quietly on a calibrated electronic scale accurate to 10 grams.
Measured: 1-21 days, 42 days, 84 days, 126 days, 180 days, 270 days, 365 days
Secondary outcomes (1)
Safety and Tolerability evaluated and recorded by parents in daily journal on stool observations at start through 365 days using VAS (Visual Analogue Scale)
- Daily stool frequency
- Stool consistency (on a five-point scale: 1 = watery, 2 = soft/pudding like, 3 = soft formed, 4 = dry formed, 5 = dry/hard pellets)
- Constipation (0 = absent, 1 = mild, 2 = moderate, 3 = severe)
- Diarrhea (0 = absent, 1 = mild, 2 = moderate, 3 = severe)
- Colic (0 = absent, 1 = mild, 2 = moderate, 3 = severe)
- Vomiting (0 = absent, 1 = mild, 2 = moderate, 3 = severe)
- Regurgitation (0 = absent, 1 = mild, 2 = moderate, 3 = severe)
- Flatulence (0 = absent, 1 = mild, 2 = moderate, 3 = severe)
- Nappy rash (0 = absent, 1 = mild, 2 = moderate, 3 = severe)
Measured: Daily through 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start8 May 2019 (estimated)
- Primary completion8 May 2020 (estimated)
- Study completion25 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Infant 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Formula feed infants will be randomized to receive either a new infant formula formulated for healthy term infants (Formula A) or a commercially available infant formula for healthy term infants (Formula B). Infants will consume the formula for a total of 52-weeks.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Worthy Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fred Worthy, Study director, Chairman, Worthy Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614468
- Sponsor's protocol ID
- 79105203
- Status last verified
- Feb 2019
- First submitted
- 17 Jul 2018
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) will be publicly available containing the abstract, background, materials and methods, study design, procedures, study formulas, measurements, statistics, results, adverse events, discussion, acknowledgements, and references.
Publications
Field CJ. The immunological components of human milk and their effect on immune development in infants. J Nutr. 2005 Jan;135(1):1-4. doi: 10.1093/jn/135.1.1.
PubMed 15623823Garcia C, Duan RD, Brevaut-Malaty V, Gire C, Millet V, Simeoni U, Bernard M, Armand M. Bioactive compounds in human milk and intestinal health and maturity in preterm newborn: an overview. Cell Mol Biol (Noisy-le-grand). 2013 Dec 30;59(1):108-31.
PubMed 25326648Jost T, Lacroix C, Braegger C, Chassard C. Impact of human milk bacteria and oligosaccharides on neonatal gut microbiota establishment and gut health. Nutr Rev. 2015 Jul;73(7):426-37. doi: 10.1093/nutrit/nuu016. Epub 2015 Apr 15.
PubMed 26081453Koletzko B, Baker S, Cleghorn G, Neto UF, Gopalan S, Hernell O, Hock QS, Jirapinyo P, Lonnerdal B, Pencharz P, Pzyrembel H, Ramirez-Mayans J, Shamir R, Turck D, Yamashiro Y, Zong-Yi D. Global standard for the composition of infant formula: recommendations of an ESPGHAN coordinated international expert group. J Pediatr Gastroenterol Nutr. 2005 Nov;41(5):584-99. doi: 10.1097/01.mpg.0000187817.38836.42.
PubMed 16254515Verwimp JJ, Bindels JG, Barents M, Heymans HS. Symptomatology and growth in infants with cow's milk protein intolerance using two different whey-protein hydrolysate based formulas in a Primary Health Care setting. Eur J Clin Nutr. 1995 Sep;49 Suppl 1:S39-48.
PubMed 8647062Szajewska H, Chmielewska A. Growth of infants fed formula supplemented with Bifidobacterium lactis Bb12 or Lactobacillus GG: a systematic review of randomized controlled trials. BMC Pediatr. 2013 Nov 12;13:185. doi: 10.1186/1471-2431-13-185.
PubMed 24215626Saha KK, Frongillo EA, Alam DS, Arifeen SE, Persson LA, Rasmussen KM. Use of the new World Health Organization child growth standards to describe longitudinal growth of breastfed rural Bangladeshi infants and young children. Food Nutr Bull. 2009 Jun;30(2):137-44. doi: 10.1177/156482650903000205.
PubMed 19689092
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Infant Formula Supports Adequate Growth and Safety Study in Healthy Infants
- ClinicalTrials.gov ID
- NCT03614468
- Acronym / sponsor ID
- 79105203
- Conditions
- Infant Development
- Keywords
- Infant Formula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Worthy HealthIndustry (pharma, biotech, devices)
- Study start
- 8 May 2019 (estimated)
- Primary completion
- 8 May 2020 (estimated)
- Study completion
- 25 May 2020 (estimated)
- First posted
- 3 Aug 2018 (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.
The objective of the present study is to evaluate the growth, safety, and tolerance in healthy, term infants consuming a new to market infant formula (Formula A) and a commercially available infant formula (Formula B) with daily weight gain as the primary outcome. As secondary outcomes, the study will evaluate other growth parameters, tolerance, and safety.
Detailed description
This is a controlled randomized parallel assignment, masked (Participant, Care Provider, Investigator, Outcomes Assessor) study. Healthy infants will be assigned an Investigational (Formula A) experimental new milk based infant formula, or an active comparator Control (Formula B) Enfamil (trademark brand name) marketed milk based infant formula. The period for the study is 365 days (52 weeks) using repeated-measures mixed model (RMMM). Anthropometry, formula intake, tolerance, and stool characteristics will be assessed. Medically confirmed adverse events will be recorded throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Formula feed infants will be randomized to receive either a new infant formula formulated for healthy term infants (Formula A) or a commercially available infant formula for healthy term infants (Formula B). Infants will consume the formula for a total of 52-weeks.
| Arm | Type | Receives |
|---|---|---|
| Formula A | Experimental | Other: Formula AAn experimental Infant Formula, Milk-Based Powder with Iron, for healthy term infants 0 to 12 months of age. |
| Formula B | Active comparator | Other: Formula BA Commercially available Infant Formula, for healthy term infants 0 to 12 months of age (Enfamil TM, Milk-Based Powder with Iron) |
Who may qualify
- Ages
- 1 day to 21 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Infants will be eligible to participate if they meet all of the following conditions. At birth the infant must be:
- Only infants whose parent(s) or legal guardian(s) have decided to feed infant formula as the sole source of nutrition, will be approached for potential study enrollment
- Healthy, term (early term/no less than 37 weeks, 0 days through late term/no greater than 41 weeks, 6 days), singleton infant
- Have a birth weight of ≥ 2500 grams
- Designated as healthy by a physician
Key exclusion criteria (8 listed)
- Infants will be ineligible if they have any of the following conditions that are judged by a physician to interfere with the infant's normal growth, development, and/or tolerance to an infant formula:
- Infants showing evidence of anatomic and physiologic defects of the respiratory tract, or other congenital defects (as determined by the clinician)
- Evidence of chronic hepatic, gastrointestinal, renal, cardiac, pulmonary, or neurological diseases
- Having a maternal history with known adverse effects on the fetus and/or the newborn infant, such as diabetes (gestational diabetes is acceptable if infant's birth weight is < 4300 g), active tuberculosis, perinatal infection,
- Having a family history of cow's milk protein intolerance/allergy
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 |
|---|---|---|
| Formula AFormula A is to be feed as the sole source of nutrition for 52 weeks to healthy term infants. | Other | Formula A |
| Formula BFormula B is to be feed as the sole source of nutrition for 52 weeks to healthy term infants. | Other | Formula B |
Primary outcome
Weight gain change measured at set intervals for first 365 days
Time frame: 1-21 days, 42 days, 84 days, 126 days, 180 days, 270 days, 365 days
The infants will be weighed naked while lying quietly on a calibrated electronic scale accurate to 10 grams.
1 secondary outcome
Safety and Tolerability evaluated and recorded by parents in daily journal on stool observations at start through 365 days using VAS (Visual Analogue Scale)
Time frame: Daily through 365 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Results publication: PubMed 15623823Field CJ. The immunological components of human milk and their effect on immune development in infants. J Nutr. 2005 Jan;135(1):1-4. doi: 10.1093/jn/135.1.1.
- Results publication: PubMed 25326648Garcia C, Duan RD, Brevaut-Malaty V, Gire C, Millet V, Simeoni U, Bernard M, Armand M. Bioactive compounds in human milk and intestinal health and maturity in preterm newborn: an overview. Cell Mol Biol (Noisy-le-grand). 2013 Dec 30;59(1):108-31.
- Results publication: PubMed 26081453Jost T, Lacroix C, Braegger C, Chassard C. Impact of human milk bacteria and oligosaccharides on neonatal gut microbiota establishment and gut health. Nutr Rev. 2015 Jul;73(7):426-37. doi: 10.1093/nutrit/nuu016. Epub 2015 Apr 15.
- Results publication: PubMed 16254515Koletzko B, Baker S, Cleghorn G, Neto UF, Gopalan S, Hernell O, Hock QS, Jirapinyo P, Lonnerdal B, Pencharz P, Pzyrembel H, Ramirez-Mayans J, Shamir R, Turck D, Yamashiro Y, Zong-Yi D. Global standard for the composition of infant formula: recommendations of an ESPGHAN coordinated international expert group. J Pediatr Gastroenterol Nutr. 2005 Nov;41(5):584-99. doi: 10.1097/01.mpg.0000187817.38836.42.
- Results publication: PubMed 8647062Verwimp JJ, Bindels JG, Barents M, Heymans HS. Symptomatology and growth in infants with cow's milk protein intolerance using two different whey-protein hydrolysate based formulas in a Primary Health Care setting. Eur J Clin Nutr. 1995 Sep;49 Suppl 1:S39-48.
- Results publication: PubMed 24215626Szajewska H, Chmielewska A. Growth of infants fed formula supplemented with Bifidobacterium lactis Bb12 or Lactobacillus GG: a systematic review of randomized controlled trials. BMC Pediatr. 2013 Nov 12;13:185. doi: 10.1186/1471-2431-13-185.
- Results publication: PubMed 19689092Saha KK, Frongillo EA, Alam DS, Arifeen SE, Persson LA, Rasmussen KM. Use of the new World Health Organization child growth standards to describe longitudinal growth of breastfed rural Bangladeshi infants and young children. Food Nutr Bull. 2009 Jun;30(2):137-44. doi: 10.1177/156482650903000205.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) will be publicly available containing the abstract, background, materials and methods, study design, procedures, study formulas, measurements, statistics, results, adverse events, discussion, acknowledgements, and references.
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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.
Fred Worthy study director
Chairman, Worthy Health
Questions about this trial
What is this clinical trial studying?
A study testing Formula A and Formula B in people with Infant Development, run by Worthy Health.
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 14 inclusion and 8 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 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Fred Worthy (310 487-9971, fred@worthy-health.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight gain change measured at set intervals for first 365 days (time frame: 1-21 days, 42 days, 84 days, 126 days, 180 days, 270 days, 365 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03614468, which also lists 7 linked publications.
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 26 Feb 2019.