Extensively Hydrolyzed Formula Growth Monitioring Study (GMS)
ConditionGrowth
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-14
SponsorMead Johnson Nutrition
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Extensively hydrolyzed casein formula (C-eHCF), commercially available
Other interventionA commercially available extensively hydrolyzed casein formula
Extensively hydrolyzed casein formula (INV-eHCF)
Other interventionAn extensively hydrolyzed casein formula
Treatment groups
214 Participants
are divided into 2 treatment groupsGroup A: Extensively hydrolyzed casein formula (C-eHCF), commercially availableActive comparator 1 intervention
Group B: Extensively hydrolyzed casein formula (INV-eHCF)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of weight gain (g/day)
Time frame
up to 131 days of ageSecondary outcomes
1
body length (cm)
Time frame
up to 131 days of age2
Head Circumference (cm)
Time frame
up to 131 days of age3
Body weight (g)
Time frame
up to 131 days of age4
Growth z-scores
head circumference-for-age
Time frame
up to 131 days of ageSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: