Extensively Hydrolyzed Formula Growth Monitoring Study

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial compares an investigational extensively hydrolyzed casein formula to a commercially available one in healthy, term infants from about 14 to 126 days old. It aims to assess growth, formula intake, stool patterns, spit-up, fussiness, sleep changes, and any health issues during the first four months of life. Both formulas have the same nutritional content per 100 kcal, and the investigational formula uses a new manufacturing process with a high-quality protein profile. Primary goals are growth and tolerability; secondary goals include intake and stool/tolerance characteristics. Enrollment is limited to certain birth and health criteria at a few US sites.

Why it matters

Who can join: the full rules

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.

Where it's running

• Alabama Clinical Therapeutics
  Birmingham, Alabama, United States Recruiting
• Alabama Clinical Therapeutics
  Birmingham, Alabama, United States Recruiting
• Childrens Clinic of Jonesboro
  Jonesboro, Arkansas, United States Recruiting
• Sprim
  Harbor Beach, Florida, United States Recruiting
• Symphony Research
  Jacksonville, Florida, United States Recruiting
• Mid Valley Research Inc.
  Moline, Illinois, United States Recruiting

Study contacts

• Study coordinator: Amy Benson
• Email: amy.benson@reckitt.com
• Phone: 812-760-9939

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.