Phase
Condition
Pediatric Health
Treatment
Experimental Formula 2
Control Formula
Experimental Formula 1
Clinical Study ID
Ages < 28 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Written informed consent has been obtained from at least one parent (or otherlegally acceptable representative [LAR]), if applicable)
Infant gestational age ≥37 completed weeks
Infant birth weight of ≥2.5 kg and ≤4.5 kg
Singleton birth
Infant postnatal age ≤28 days (date of birth = day 0)
Mother has previously decided to fully formula-feed, and infant is no longerbreastfeeding or receiving breast milk
Infant's parent(s)/LAR is of legal age of majority, must understand the informedconsent form and other relevant study documents, and is willing and able to fulfillthe requirements of the study protocol
Exclusion
Exclusion Criteria:
Chronic infectious, metabolic, genetic illness or other disease, including anycondition that impacts feeding or growth
Major congenital or chromosomal abnormality known to affect growth (e.g., congenitalheart disease, cystic fibrosis)
Maternal medical conditions known to affect infant growth (e.g., untreatedpreeclampsia or gestational diabetes)
Infants with special dietary needs other than standard infant formula
Infants with known (or symptoms suggestive of) cow's milk proteinintolerance/allergy, or lactose intolerance or severe food allergies that impactdiet
Child has other medical or psychiatric condition that, in the judgement of theinvestigator, would make the child inappropriate for entry into the study
Currently participating or having participated in another interventional clinicaltrial prior to enrollment
Study Design
Connect with a study center
National Guard Hospital
Jeddah,
Saudi ArabiaActive - Recruiting
King Faisal Specialist Hospital and Research Center
Riyadh,
Saudi ArabiaCompleted
National Guard Hospital
Riyadh,
Saudi ArabiaSite Not Available
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