Last updated: October 5, 2023
Sponsor: Société des Produits Nestlé (SPN)
Overall Status: Active - Recruiting
Phase
N/A
Condition
Pediatric Health
Treatment
Experimental Formula 1
Control Formula
Experimental Formula 2
Clinical Study ID
NCT05868408
21.10.INF
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 other legallyacceptable 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 protein intolerance/allergy,or lactose intolerance or severe food allergies that impact diet
- 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
Total Participants: 234
Treatment Group(s): 3
Primary Treatment: Experimental Formula 1
Phase:
Study Start date:
August 17, 2023
Estimated Completion Date:
July 31, 2025
Connect with a study center
National Guard Hospital
Jeddah,
Saudi ArabiaActive - Recruiting
King Faisal Specialist Hospital and Research Center
Riyadh,
Saudi ArabiaSite Not Available
National Guard Hospital
Riyadh,
Saudi ArabiaActive - Recruiting
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