New Infant Formula Supports Adequate Growth in Healthy Infants

February 24, 2019 updated by: Worthy Health

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 3 weeks (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

  1. Healthy, term (early term/no less than 37 weeks, 0 days through late term/no greater than 41 weeks, 6 days), singleton infant
  2. Have a birth weight of ≥ 2500 grams

At the time of the baseline/enrollment visit, infants must be:

  1. Designated as healthy by a physician
  2. ≤21 days post-natal age (Date of Birth = Day 0)
  3. Weight for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
  4. Length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
  5. Head circumference for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
  6. Weight for length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
  7. Exclusively consuming and tolerating a cow's milk infant formula at time of enrollment
  8. 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
  9. 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.

Exclusion Criteria:

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:

  1. Infants showing evidence of anatomic and physiologic defects of the respiratory tract, or other congenital defects (as determined by the clinician)
  2. Evidence of chronic hepatic, gastrointestinal, renal, cardiac, pulmonary, or neurological diseases
  3. 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,
  4. Having a family history of cow's milk protein intolerance/allergy
  5. Are an infant from a multiple birth (twin, triplet, etc.)
  6. Mothers who smoked cigarettes
  7. Mothers who used illicit drugs during pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Formula A
An experimental Infant Formula, Milk-Based Powder with Iron, for healthy term infants 0 to 12 months of age.
Other: Formula A
Formula A is to be feed as the sole source of nutrition for 52 weeks to healthy term infants.
ACTIVE_COMPARATOR: Formula B
A Commercially available Infant Formula, for healthy term infants 0 to 12 months of age (Enfamil TM, Milk-Based Powder with Iron)
Other: Formula B
Formula B is to be feed as the sole source of nutrition for 52 weeks to healthy term infants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1-21 days, 42 days, 84 days, 126 days, 180 days, 270 days, 365 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
  1. Daily stool frequency
  2. Stool consistency (on a five-point scale: 1 = watery, 2 = soft/pudding like, 3 = soft formed, 4 = dry formed, 5 = dry/hard pellets)
  3. Constipation (0 = absent, 1 = mild, 2 = moderate, 3 = severe)
  4. Diarrhea (0 = absent, 1 = mild, 2 = moderate, 3 = severe)
  5. Colic (0 = absent, 1 = mild, 2 = moderate, 3 = severe)
  6. Vomiting (0 = absent, 1 = mild, 2 = moderate, 3 = severe)
  7. Regurgitation (0 = absent, 1 = mild, 2 = moderate, 3 = severe)
  8. Flatulence (0 = absent, 1 = mild, 2 = moderate, 3 = severe)
  9. Nappy rash (0 = absent, 1 = mild, 2 = moderate, 3 = severe)
Daily through 365 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Worthy Health

Investigators

  • Study Director: Fred Worthy, Chairman, Worthy Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 8, 2019

Primary Completion (ANTICIPATED)

May 8, 2020

Study Completion (ANTICIPATED)

May 25, 2020

Study Registration Dates

First Submitted

July 17, 2018

First Submitted That Met QC Criteria

July 30, 2018

First Posted (ACTUAL)

August 3, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 24, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 79105203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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