Growth and Tolerance of a Partially Hydrolyzed Infant Formula

Completed · Not applicable

Conditions studied: Growth

In brief

The purpose of this research study is to compare the growth and tolerance of infants who consume either an infant formula with intact proteins or an infant formula with partially hydrolyzed proteins through approximately 12 months of age.

Key facts

Study ID

NCT05047978

Run by

Mead Johnson Nutrition

People needed

244

Starts

2021-08-28

Expected to finish

2023-11-21

Last updated by the study team

2024-01-23

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 10 to 14 days of age at randomization
• singleton birth
• Gestational age of 37 to 42 weeks
• Birth weight of 2500 g (5lbs 8oz or more)
• Exclusively receiving infant formula for at least 24 hours prior to randomization
• Parent or legal guardian has full intention to exclusively feed study formula through 120 days of age
• Parent or legal guardian agrees not to enroll infant in another interventional clinical study while participating in this study
• Signed informed consent and authorization to use and disclose Protected Health information

You may not qualify if…

• History of underlying metabolic or chronic disease
• Evidence of feeding difficulties or history of formula intolerance
• Weight at Visit 1 is <98% of birth weight
• Infant was born large for gestational age from a mother who was diabetic at childbirth
• Infant is immunocompromised

Where it is running

• Birmingham Pediatric Associates — Birmingham, Alabama, United States
• Southeastern Pediatric Associates — Dothan, Alabama, United States
• Visions Clinical Research-Tucson — Tucson, Arizona, United States
• Northwest Arkansas Pediatric Clinic — Fayetteville, Arkansas, United States
• The Children's Clinic of Jonesboro — Jonesboro, Arkansas, United States
• PAS Research — Tampa, Florida, United States
• Rophe Adult & Pediatric Medicine — Union City, Georgia, United States
• Saltzer Health — Nampa, Idaho, United States
• Springs Medical Research — Owensboro, Kentucky, United States
• Meridian Clinical Research — Grand Island, Nebraska, United States
• The Jackson Clinic — Jackson, Tennessee, United States
• DCOL Center for Clinical Research — Longview, Texas, United States
• PAS Research — McAllen, Texas, United States

Full record on ClinicalTrials.gov

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