Extensively Hydrolyzed Formula Growth Monitioring Study (GMS)

Official title

GROWTH AND TOLERANCE OF A NEW INFANT FORMULA USING AN EXTENSIVELY HYDROLYZED CASEIN-BASED PROTEIN (eHCF)

Overview

This is a research study to compare an investigational infant formula against a currently marketed infant formula. An investigational infant formula is one that has never been approved by the United States Food and Drug Administration (FDA). The purpose of this research study is to evaluate the growth and tolerance of infants who consume a new (not yet available to buy) extensively hydrolyzed cow milk protein infant formula compared to an extensively hydrolyzed cow milk protein infant formula that is currently available to buy. The study will also look at the growth of your baby, how many poops your baby has, what the poops are like (for example, soft or hard), how much study formula your baby drinks, how well your baby handles the study formula (such as spit-up, fussiness, gas, colic, or changes in sleep), and any health problems that might come up during the study.

Detailed description

The current study is designed to demonstrate that an investigational extensively hydrolyzed casein formula developed utilizing a new manufacturing process, is well-accepted, tolerated and supports typical growth similar to a control extensively hydrolyzed casein formula in term, healthy infants from approximately 14 to 126 days of age. This formula has been determined to have a high-quality protein similar to that of intact casein, as seen in the protein efficiency ratio (PER) study. Secondary objectives will include tolerance, intake and stool characteristics between infants assigned to receive the control or the investigational formula through approximately 126 days of age. Control and investigational formulas have the same nutritional composition per 100 kcal.

Interventions

• Other Extensively hydrolyzed casein formula (C-eHCF), commercially available
  A commercially available extensively hydrolyzed casein formula
• Other Extensively hydrolyzed casein formula (INV-eHCF)
  An extensively hydrolyzed casein formula

Primary outcome measures

• Rate of weight gain (g/day) [Time frame: up to 131 days of age]

Secondary outcome measures (10)

• body length (cm) [Time frame: up to 131 days of age]
• Head Circumference (cm) [Time frame: up to 131 days of age]
• Body weight (g) [Time frame: up to 131 days of age]
• Growth z-scores [Time frame: up to 131 days of age]
• Growth Z Scores [Time frame: up to 131 days of age]
• Growth Z Scores [Time frame: up to 131 days of age]
• Stool characteristics [Time frame: up to 131 days of age]
• Study formula intake [Time frame: up to 131 days of age]
• Tolerance [Time frame: up to 131 days of age]
• Medically confirmed adverse events [Time frame: up to 131 days of age]

Eligibility criteria

Inclusion criteria

• 10 to 14 days of age at randomization, inclusive (day of birth is considered Day 0)
• Singleton birth
• Gestational age of 37 weeks + 0 days to 41 weeks + 6 days, inclusive
• Birth weight of 2500 g to 4200 g, inclusive
• Birth weight appropriate for gestational age (AGA, defined as birth weight-for-age between 10th and 90th percentile, inclusive)
• Exclusively receiving infant formula for at least 24 hours prior to randomization
• Parent(s) or legal guardian(s) have full intention to exclusively feed their infant study formula through 126 days of age
• Signed informed consent obtained from parent or legal guardian for infant's participation in the study
• Signed authorization obtained from parent or legal guardian to use and/or disclose Protected Health Information for the infant from birth through the length of the study period
• Parent or legal guardian agrees not to enroll the infant in another interventional clinical study while participating in this study
• Decentralized participant's parent/caregiver or legal guardian has access to reliable internet and technology for remote visits.
• Decentralized participant's parent/caregiver or legal guardian anticipates having a second adult available for all remote visits.

Exclusion criteria

• History of underlying metabolic or chronic disease; congenital malformation; immunodeficiency, gastrointestinal condition, or any other condition which, in the opinion of the Investigator, is likely to interfere with: the ability of the infant to ingest food by mouth, the normal growth and development of the infant, or the evaluation of the infant
• Evidence of feeding difficulties or history of formula intolerance, such as vomiting or poor intake at time of randomization
• First degree relative (if known) history of cow's milk protein intolerance or allergy
• Maternal history with known adverse effects on the fetus and/or newborn infant in the opinion of the investigator, such as, but not limited to diabetes, smoking, active tuberculosis, perinatal infection, or substance abuse
• Weight at Visit 1 is <98% of birth weight \[weight at Visit 1÷ birth weight) x 100< 98%\]
• Infants whose parent, legal guardian, or first-degree relative is an employee of MJN/Reckitt or an affiliated vendor (e.g., CRO, laboratory, or data management provider) involved in the clinical trial, and who is directly or indirectly engaged in the design, conduct, oversight, or analysis of the study; has access to confidential study information; or holds supervisory authority over personnel involved in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Other

Study locations

United States · 12 centers

• Alabama Clinical Therapeutics — Birmingham
• Alabama Clinical Therapeutics — Birmingham
• Childrens Clinic of Jonesboro — Jonesboro
• SPRIM — Harbor Beach
• Symphony Research — Jacksonville
• Hope Research Network — Virginia Gardens
• Mid Valley Research Inc. — Moline
• Springs Medical Research — Owensboro
• … and 4 more centers

Identifiers

NCT: NCT07513506 · 3397-2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗