Growth and safety Outcomes in infants with CMPA fed a novel extensively hydrolyzed formula.
Full-term infant(gestational age ≥37 weeks and ≤42 weeks).
Birth weight ≥2500 g and ≤4500 g.
Parent(s)/LAR deemed able to provide written informed consent for participation of their infant in the study (in the opinion of the investigator).
Participant aged ≥29 days (>4 weeks) and <5 months (≤22 weeks) at time of enrollment.
Prior use of eHF, HRF or AAF for more than 2 weeks before randomization.
Congenital illness or malformation that may affect growth, or significant pre-natal and/or serious post-natal disease other than CMPA before randomization (per investigator's medical decision).
Demonstrated chronic malabsorption not due to CMPA.
History of severe anaphylaxis to CMP.
Parallel
New generation eHF
Dietary supplementNew generation of a whey-based eHF formula intended for the dietary management of infants with CMPA.
Commercial eHF
Dietary supplementCommercial whey-based eHF formula intended for the dietary management of infants with CMPA.
Weight Gain Over 16 Weeks
To demonstrate non-inferiority in growth in infants fed with the Test formula, compared to infants fed with the Control formula over the first 16 weeks of formula intake.
Incidence of Adverse Events of Special Interest (AESIs)
To evaluate the safety and tolerability of the Test formula, including effects on "adverse events of special interest (AESIs)", which include lower respiratory tract infections (LRTIs), upper respiratory tract infections (URTIs), ear infections/otitis media, gastrointestinal infections and other viral or bacterial infections including urinary tract infections (UTIs).
Growth Parameters: Weight
The growth by body weight (in g) of infants over 52 weeks.
Growth Parameters: Length
The growth by body length (in cm) of infants over 52 weeks
Quality of Life Scores (ITQOL)
Quality of life over 52-weeks assessed by validated Quality of Life (QoL) scale: Infant and Toddler Quality of Life \[ITQOL\] Minimum score: 0 Maximum score: 100 Interpretation: Higher scores indicate better health-related quality of life, better functioning, or less negative impact on the child/family (depending on the specific domain). A score of 0 represents the worst health/status, while 100 represents the best health/status
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