Is NCT07513506 recruiting in Wilmington, NC?

Yes, NCT07513506 is currently recruiting participants at its Wilmington, NC location. This growth clinical trial is actively enrolling qualified participants.

How do I join the growth clinical trial in Wilmington?

To join this clinical trial in Wilmington, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Wilmington clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Growth Clinical Trial in Wilmington, NC

About This Growth Study in Wilmington

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.

Sponsor: Mead Johnson Nutrition

Who Can Participate

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Wilmington?

Yes, this clinical trial (NCT07513506) has an active research site in Wilmington, NC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Growth Treatment Options in Wilmington, NC

If you're searching for growth treatment options in Wilmington, NC, this clinical trial (NCT07513506) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Wilmington research site is actively enrolling participants for this clinical trial. You'll receive care from experienced growth specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all growth clinical trials near you to find additional studies recruiting in your area.

Growth Clinical Trial in Wilmington, NC

Expert Care in Wilmington

IRB Approved

No-Cost Care

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