Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy … (NCT05868408) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants
Saudi Arabia234 participantsStarted 2023-08-17
Plain-language summary
This study will assess the effect of partially hydrolyzed, whey-based infant formulas on growth and gastrointestinal tolerance in healthy term infants.
Who can participate
Age range0 Days – 28 Days
SexALL
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Inclusion criteria
✓. Written informed consent has been obtained from at least one parent (or other legally 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 longer breastfeeding or receiving breast milk
✓. Infant's parent(s)/LAR is of legal age of majority, must understand the informed consent form and other relevant study documents, and is willing and able to fulfill the requirements of the study protocol
Exclusion criteria
✕. Chronic infectious, metabolic, genetic illness or other disease, including any condition that impacts feeding or growth
✕. Major congenital or chromosomal abnormality known to affect growth (e.g., congenital heart disease, cystic fibrosis)
✕. Maternal medical conditions known to affect infant growth (e.g., untreated preeclampsia 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
What they're measuring
1
Difference in growth in first 4 months of life between control and experimental groups
Timeframe: From enrollment to age 4 months
2
Equivalence in growth in first 4 months of life in experimental groups
✕. Child has other medical or psychiatric condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study
✕. Currently participating or having participated in another interventional clinical trial prior to enrollment